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EVIDENCE BASED NURSING

EFEKTIVITAS AKUPUNTUR PADA PASIEN INSOMNIA

KEPERAWATAN KOMPLEMENTER

Oleh
Yuli Agustin
NIM 162310101238
Kelas E - 2016

Dosen Pengampu : Ns. Mulia Hakam, M.Kep., Sp.Kep.MB

PROGRAM STUDI SARJANA KEPERAWATAN


FAKULTAS KEPERAWATAN
UNIVERSITAS JEMBER
2018/2019
EVIDENCE BASED NURSING
EFEKTIVITAS AKUPUNTUR PADA PASIEN INSOMNIA

Disusun untuk memenuhi tugas mata kuliah Keperawatan Komplementer

Oleh
Yuli Agustin
NIM 162310101238
Kelas E - 2016

Dosen Pengampu : Ns. Mulia Hakam, M.Kep., Sp.Kep.MB

PROGRAM STUDI SARJANA KEPERAWATAN


FAKULTAS KEPERAWATAN
UNIVERSITAS JEMBER
2018/2019

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DAFTAR ISI

Halaman
HALAMAN SAMPUL ............................................................................... ii
DAFTAR ISI .............................................................................................. iii
BAB 1. PENDAHULUAN .......................................................................... 1
1.1 Latar Belakang .................................................................................. 1
1.2 Tujuan ............................................................................................... 2
1.3 Manfaat ............................................................................................. 2
BAB 2. METODOLOGI PENELITIAN ................................................... 3
2.1 Analisis PICO (Problem, Intervention, Comparative, Outcome) ......... 3
2.2 Pertanyaan Klinis ............................................................................... 3
2.3 Metode Penelusuran Jurnal ................................................................ 4
2.4 Jurnal Database Yang Digunakan ...................................................... 4
2.5 Temua Artikel Pilihan Dari Kata Kunci PICO ................................... 4
BAB 3. PROSEDUR APLIKASI ............................................................... 7
3.1 Subjek ............................................................................................... 7
3.2 Kriteria Inklusi .................................................................................. 7
3.3 Kriteria Eksklusi ................................................................................ 7
3.4 Prosedur Pelaksanaan EBN ................................................................ 8
BAB 4. PEMBAHASAN ............................................................................ 10
4.1 Kefektifan Terapi Akupuntur pada Pasien Insomnia .......................... 10
BAB 5. PENUTUP ..................................................................................... 12
5.1 Kesimpulan ....................................................................................... 12
5.2 Saran ................................................................................................. 12
DAFTAR PUSTAKA ................................................................................. 13
LAMPIRAN ............................................................................................... 14

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BAB 1. PENDAHULUAN

1.1 Latar Belakang


Insomnia adalah ketidakmampuan atau kurangnya jumlah jam tidur yang
dibutuhkan individu, sehingga bisa bangun dengan perasaan yang segar. Karena
setiap orang memiliki kebutuhan tidur yang berbeda. Insomnia ini bukan berarti
berapa jam individu tidur atau seberapa individu cepat tertidur, namun insomnia
ditentukan oleh kualitas tidur dan bagaimana perasaan setelah tidur (Pahul, 2016).
Menurut American Academy of Sleep Medicine (2008), prevalensi orang
dewasa yang mengalami insomnia di Amerika adalah 10% insomnia cukup parah,
30% insomnia memiliki gejala insomnia dan kurang dari 10% mengalami
insomnia kronis. Hal ini berbeda dengan penelitian yang dilakukan oleh Xuan Yin
dkk (2017), prevalensi insomnia meningkat sekitar 23.3% dari pupulasi orang
dewasa di Amerika Serikat mengalami insomnia. Selain itu di China insiden
insomnia ini meningkat hingga 45,5%.
Faktor risiko yang menyebabkan individu mengalami insomnia adalah
bertambahnya usia, jenis kelamin perempuan, gangguan komorbiditas (medis,
psikiatris, tidur dan penggunaan narkoba), kerja shift dan mungkin pengangguran
atau status sosial ekonomi yang rendah (Rodin dkk, 2017). Sedangkan insomnia
primer adalah kesulitan tidur setiap hari, penyababnya bukan karena gangguan
tidur lain, gangguan mental atau dampak fisiologis dari zat atau kondisi medis.
Gangguan tidur insomnia ini berkaitan erat dengan kelelahan, penurunan
kewaspadaan dan gangguan konsentrasi dan lain-lain. Insomnia juga merupakan
faktor risiko yang dapat mengurangi kekebalan tubuh (Yin, 2017).
Akupuntur adalah cara pengobatan dengan menusukkan jarum pada titik-
titik tertentu di kulit untuk menghilangkan nyeri dan mengobati kesehatan tertentu
(Hidayat dkk, 2015). Manfaat dari akupuntur adalah menyeimbangkan tubuh dan
mengembalikan fungsi fisiologis dengan memasukkan jarum tipis didaerah
tertentu / akupoint. Intervensi akupuntur dapat meningkatkan kandungan
serotonin, asam aminobutryic dan mengurangi kadar glutamate. Manfaat dari

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serotonin sendiri dapat meningktakan mood individu, sehingga dapat dijadikan
sebagai intervensi untuk mengatasi masalah insomnia (Yin, 2017).

1.2 Tujuan
1.2.1 Tujuan Umum
Mengetahui keefektifan terapi komplementer akupuntur untuk mengatasi
insomnia
1.2.2 Tujuan Khusus
1.2.2.1 Mengetahui kejadian insomnia
1.2.2.2 Mengetahui manfaat akupuntur sebagai intervensi untuk mengatasi
masalah insomnia
1.2.2.3 Mengetahui keefektifan akupuntur sebagai intervensi untuk mengatasi
masalah insomnia

1.3 Manfaat Penerapan Evidance Based Nursing (EBN)


1.3.1 Manfaat bagi Penulis
Dapat menambah pengetahuan serta informasi dalam memberikan intervensi
dalam keperawatan khususnya terkait dengan terapi komplementer yaitu
keefektifan akupuntur dalam menangani insomnia.
1.3.2 Manfaat bagi Instasi Kesehatan
Dapat menambah materi pembelajaran yang kemudian dapat didiskusikan
dan diaplikasikan pada pasien insomnia
1.3.3 Manfaat bagi Perawat
Dapat menjadi tambahan informasi dalam memberikan tindakan dalam
asuhan keperawatan yang tidak bergantung pada tindakan medis.
1.3.3 Manfaat bagi Masyarakat
Dapat menjadi referensi dalam pilihan pengobatan konvensional. Utamanya
dalam mengatasi masalah insomnia.

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BAB 2. METODOLOGI PENELITIAN

2.1 Analisis PICO (Problem, Intervention, Comparative, Outcome)


Problem : Insomnia primer adalah kesulitan tidur setiap hari, penyababnya bukan
karena gangguan tidur lain, gangguan mental atau dampak fisiologis dari zat atau
kondisi medis. Insiden insomnia ini meningkat di dunia, sekitar 23.3% dari
pupulasi orang dewasa di Amerika Serikat mengalami insomnia. Selain itu di
China insiden insomnia ini meningkat hingga 45,5%. Gangguan tidur insomnia ini
berkaitan erat dengan kelelahan, penurunan kewaspadaan dan gangguan
konsentrasi dan lain-lain. Insomnia juga merupakan faktor risiko yang dapat
mengurangi kekebalan tubuh. Saat ini pengobatan utama untuk insomnia adalah
perawatan psikologis dan konsumsi obat. Obat yang digunakan benzodiazepine,
barbiturate dan obat penenang lainnya. Penggunaan obat tersebut dalam jangka
panjang menyebabkan sedasi berlebihan, toleransi, kecanduan dan toksisitas
neurologis.

Intervention : Intervensi yang dapat dilakukan untuk mengatasi masalah insomnia


primer ini adalah aplikasi akupuntur. Intervensi akupuntur diberikan pada kepada
kelompok eksperimen sebanyak 36 responden selama empat minggu.

Comparative : Intervensi akupuntur palsu diberikan pada kelompok kontrol


sebanyak 36 responden selama empat minggu.

Outcome : Intervensi penggunaan akupuntur sebagai pengobatan pasien insomnia


primer ini diharapkan dapat mengatasi masalah insomnia. Sehingga efisiensi tidur,
total waktu tidur dan kualitas tidur pasien dapat meningkat.

2.2 Pertanyaan Klinis


Apakah intervensi akupuntur pada enam akupoint tertentu dapat membnatu
menangani masalah pasien insomnia primer ?

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2.3 Metode Penelusuran Jurnal
Unsur PICO
Analisis Kata Kunci
(Terapi)
Complementary therapy for
P Insomniac disease
patient with insomniac
Acupuncture Treatment
I Terapi komplementer akupuntur
On Insomnia
C Terapi akupuntur palsu
Menangangani insomnia,
efisiensi tidur, total waktu tidur
O
dan kualitas tidur pasien dapat
meningkat.

2.4 Jurnal Database yang Digunakan


Menggunakan kata kunci dan beberapa sinonimnya dari analisa PICO penulis
memasukkannya ke dalam search engine jurnal sebagai berikut :
a. https://www.ncbi.nlm.nih.gov/
b. https://www.guideline.gov/
c. https://www.sciencedirect.gov/
didapatkan 87 judul jurnal, kemudian dipilih sebanyak 5 jurnal yang relevan.
Jurnal yang relevan dipilih lagi menjadi 3 jurnal, yaitu 1 jurnal utama, 1 jurnal
sebagai pendukung dan 1 jurnal untuk pembanding.

2.5 Temuan Artikel Pilihan dari Kata Kunci PICO


Jurnal rujukan utama pelaksana EBN : Efficacy And Safety Of Acupuncture
Treatment On Primary Insomnia: A Randomized Controlled Trial (2017)
Efektivitas Dan Keamanan Pengobatan Akupuntur Pada Insomnia Primer :
Uji Coba Terkontrol Secara Acak

Tujuan : Tujuan dari penelitian ini adalah untuk mengevaluasi afektivitas dan
keamanan pengobatan akupuntur untuk insomnia primer
Metode : Uji klinis yang dilakukan pada 72 pasien dengan insomnia primer. 72
pasien tersebut dibagi menjadi dua kelompok yaitu kelompok akupuntur
(menerima intervensi/perawatan akupuntur) dan kelompok kontrol (menerima
intervensi/perawatan akupuntur palsu). Perawatan/intervensi kepada pasien
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diberikan tiga kali seminggu selama empat minggu. Pasien diminta untuk
memakai monitor tidur dan mengisi kuesioner setiap dua minggu dengan total
delapan minggu.
Hasil : Dibandingkan sebelum dilakukan intervensi/perawatan akupuntur pada
pasien insomnia, kedua kelompok akupuntur dan kontrol memiliki tingkat
perbaikan yang berbeda terhadap kondisi tidur mereka. Terdapat perbedaan yang
signifikan pada kelompok akupuntur sebelum dan sesudah perawatan akupuntur.
Hasilnya menunjukkan skor Insomnia Severity Index (ISI) meningkat secara
drastis pada kelompok akupuntur pada empat minggu setelah diberikan
perawatan. Selain itu terdapat peningkatan pada skor tidur termasuk sleep
efficiency (SE) / efisiensi tidur, total sleep time (TST) / total waktu tidur dan the
self-rating depression scale (SDS) / skala depresi. Penurunan skor sleep
awakenings (SA) / bangun tidur dan the self-rating anciety scale (SAS) / skor
skala kecemasan terjadi pada kelompok yang diberikan keperawatan akupuntur
selama empat minggu.
Kesimpulan : Pengobatan akupuntur lebih efektif daripada akupuntur palsu
terhadap pasien insomnia. Pengobatan akupuntur dapat meningktakan kualitas
tidur pasien dan meningkatkan kesehatan psikologis mereka.

Jurnal pendukung EBN : Effect Of Acupuncture On Patients With Insomnia :


Study Protocol For A Randomized Controlled Trial (2014)
Efek Akupuntur Pada Pasien Dengan Insomnia : Studi Protocol
Untuk Ujia Coba Terkontrol Secara Acak

Tujuan : Untuk mengetahui kemanjuran atau efektifitas akupuntur sebagai


pengobatan insomnia
Metode : Sebanyak 38 pasien melakukan tes skrining pada hari pertama, terdaftar
dalam uji klinis dan kemudian secara acak di masukkan dalam kelompok
perawatan/intervensi dan kelompok kontrol (19 pasien untuk setiap kelompok).
Sunjek yang digunakan adalah pasien insomnia dengan skor 6 atau lebih sesuai
penilaian Pittsburgh Sleep Quality Index (PSQI). Setiap subjek diberikan
intervensi dengan akupuntur intradermal (IDA), akupuntur nyata (PC6, SP6,

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HT7,KI6 dan BL62) untuk kelompok eksperimen. Sedangkan untuk kelompok
kontrol diberikan akupuntur palsu. Akupuntur palsu lebih dari 1 cm dari
akupuntur nyata. Intervensi ini dilakukan tiga kali selama seminggu.
Hasil : Hasil dari penelitian ini adalah efek akupuntur nyata pada kelompok
intervensi/eksperimen sebanyak tiga kali selama seminggu mampu mengatasi
masalah insomnia pada responden, namun tidak cukup signifikan. Hal ini dapak
diketahui pada skala Insomnia Severity Index (ISI).
Kesimpulan : Terapi komplementer akupuntur dapat digunakan sebagai
alternative pengobatan untuk insomnia

Jurnal pembanding EBN : Self-Administered Acupressure For Insomnia


Disorder : A Pilot Randomized Controlled Trial (2018)
Penggunaan Akupressure Secara Mandiri Untuk Menangani Gangguan
Insomnia : Uji Coba Terkontrol Secara Acak

Tujuan : Mengevaluasi jangka pendek terkait intervensi acupressure untuk


mengurangi insomnia
Metode : Sebanyak 31 subjek dengan gangguan insomnia dipilih dari suatu
komunitas. Setiap subjek menerima dua pengetahuan terkait penggunaan
acupressure secara mandiri atau pendidian kesehatan tidur. Subjek yang
digunakan dibagi menjadi dua kelompok, yaitu kelompok acupressure dan subjek
pembanding. Kelompok acupressure diajarkan terkait bagaimana cara
mempraktikkan acupressure secara mandiri setiap hari selama empat minggu.
Sedanggkan untuk kelompok pembanding hanya disarankan untuk mengikuti
pendidikan terkait kebersihan tidur.
Hasil : Kelompok eksperimen/acupressure mendapatkan hasil bahwa skala
kecemasannya turun disbanding dengan kelompok pembanding/pendidikan terkait
kebersihan tidur. Selain itu kepatuhan terhadap praktik acupressure secara
mandiripun dinilai memuaskan dengan presentase 92,3%.
Kesimpulan : Acupressure yang dipraktikkan secara mandiri pada kelompok
intervensi dapat mengatasi masalah insomnia.

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BAB 3. PROSEDUR APLIKASI

Pelaksanaan EBN ini mengacu pada penelitian Yian, X dkk (2017) dengan
judul “Efficacy And Safety Of Acupuncture Treatment On Primary Insomnia: A
Randomized Controlled Trial”.

3.1 Subjek
Pasien yang mengalami gangguan insomnia

3.2 Kriteria Inklusi


Beberapa kriterian inklusi yang digunakan dalam penelitian :
1. Berusia 18 sampai 65 tahun
2. Memenuhi kriteria diagnostic insomnia sesuai dengan diagnostic and
statistical manual of mental disorders
3. Mengalami insomnia selama lebih dari sebulan namun kurang dari dua tahun
4. Keparahan insomnia, dilihat dari skor Insomnia Severity Index (ISI) lebih dari
8 poin, namun kurang dari 21 poin.
5. Menyetujui secara sukarela terkait investigasi dan menandatangani formulir
tertulis untuk uji klinis.

3.3 Kriteria Eksklusi


Beberapa kriterian ekslusi yang digunakan dalam penelitian :
1. Pasien yang memiliki penyakit kardiovaskuler, hati, ginjal atau system
hematopoietic yang serius
2. Insomnia pasien disebabkan oleh penyakit system saraf (misalnya, stroke,
penyakit Parkinson)
3. Insomnia pasien yang disebabkan oleh gangguan mental termasuk depresi
atau kecemasan
4. Pasien memiliki riwayat sleep apnea
5. Wanita hamil atau menyusui

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6. Pasien yang menggunakan obat antidepresan atau obat antipsikotik dua
minggu sebelum penelitian
7. Pasien yang berusia >65 tahun, pasien depresi atau gangguan tidur lain,

3.4 Prosedur Pelaksanaan EBN


Berikut prosedur pelaksanaan EBN :
1. Peserta diminta menggunakan masker mata untuk mendaptkan istirahat yang
baik dan efek terapi yang baik
2. Baihui (GV20) : sudut antara jarum dan kulit kepala 30o. pindahkan ujung
jarum ke belakang sepanjang garis tengah posterior anterior dan kemudian
masukkan jarum 0,5 cun / 0,3x40 mm
3. Shenting (GV24) : sudut antara jarum dan kulit kepala 30 o. pindahkan ujung
jarum ke belakang sepanjang garis tengah posterior anterior dan kemudian
masukkan jarum 0,5 cun / 0,3x25 mm
4. Yintang (GV29) : jepit kulit local kemudian tusuk dengan miring 0,5 cun /
0,3x25 mm
5. Anmian (EX-HN22) : sudut antara ujung jarum dan kulit kepala adalah 30 o.
tusukan sedalam 0,5 cun dengan ujung jarum mengarah ke ujung hidung.
6. Shenmen (HT7) : tusukan secara tegak lurus 0,5 cun / 0,3x25 mm
7. SanYinjiao (SP6) : tusukan secara tegak lurus 1-1,5 cun / 0,3x40 mm
8. Jarum akupuntur masuk dengan kedalaman 17-25 mm pada setiap akupuntur
9. Setiap intervensi berlangsung selama 30 menit

Sumber : Efficacy And Safety Of Acupuncture Treatment On Primary Insomnia:


A Randomized Controlled Trial (2017)

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10. Perbedaan kelompok kontrol dan intervensi tidak ada nya jarum dalam tabung
pada kelompok kontrol. Peneliti hanya meletakkan tabung di titi akupoint
kemudian mengetuknya seolah-olah terasa/memberi sensasi jarum yang nyata

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BAB 4. PEMBAHASAN

4.1 Kefektifan Terapi Akupuntur pada Pasien Insomnia


Insomnia primer adalah kesulitan tidur setiap hari, penyababnya bukan
karena gangguan tidur lain, gangguan mental atau dampak fisiologis dari zat atau
kondisi medis. Insomnia disebabkan oleh inisiasi tidur atau gangguan perawatan,
termasuk kesulitan tidur, mimpi dan kurang tidur. Insiden insomnia ini meningkat
di dunia, sekitar 23.3% dari pupulasi orang dewasa di Amerika Serikat mengalami
insomnia. Selain itu di China insiden insomnia ini meningkat hingga 45,5%.
Gangguan tidur insomnia ini berkaitan erat dengan kelelahan, penurunan
kewaspadaan dan gangguan konsentrasi dan lain-lain. Insomnia juga merupakan
faktor risiko yang dapat mengurangi kekebalan tubuh.
Akupuntur adalah salah satu yang paling popular dan terapi paling aman.
Akupuntur sudah digunakan sebagai pengobatan untuk insomnia di China.
Manfaat dari akupuntur adalah menyeimbangkan tubuh dan mengembalikan
fungsi fisiologis dengan memasukkan jarum tipis didaerah tertentu / akupoint.
Intervensi akupuntur dapat meningkatkan kandungan serotonin, asam
aminobutryic dan mengurangi kadar glutamate.
Berdasarkan penelitian ini untuk mengetahui keefektifan dari terapi
komplementer akupuntur ini dibedakan menjadi dua kelompok, yaitu kelompok
intervensi akupuntur/eksperimen dan kelompok konntrol/akupuntur palsu. Terapi
akupuntur ini memiliki 6 titik antara lain, baihui (GV20), shenting (GV24),
yintang (GV29), anmian (EX-HN22), shenmen (HT7), sanyinjiao (SP6). Setiap
titik itu berlangsung selama 30 menit dan intervensinya diberikan tiga kali dalam
seminggu selama empat minggu. Kelompok intervensi/eksperimen mendapatkan
terapi akupuntur di enam akupoint tersebut. Sedangkan pada kelompok kontrol
tidak ada nya jarum dalam tabung pada kelompok kontrol. Peneliti hanya
meletakkan tabung di titi akupoint kemudian mengetuknya seolah-olah
terasa/memberi sensasi jarum yang nyata
Penelitian terapi akupuntur pada enam titik tersebut berlangsung selama
empat minggu dan didapatkan hasil bahwa pada kelompok intervensi dan kontrol

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memiliki tingkat perbaikan yang berbeda terhadap kondisi tidur mereka. Terdapat
perbedaan yang signifikan pada kelompok akupuntur sebelum dan sesudah
perawatan akupuntur. Hasilnya menunjukkan skor Insomnia Severity Index (ISI)
meningkat secara drastis pada kelompok akupuntur pada empat minggu setelah
diberikan perawatan. Selain itu terdapat peningkatan pada skor tidur termasuk
sleep efficiency (SE) / efisiensi tidur, total sleep time (TST) / total waktu tidur dan
the self-rating depression scale (SDS) / skala depresi. Penurunan skor sleep
awakenings (SA) / bangun tidur dan the self-rating anciety scale (SAS) / skor
skala kecemasan terjadi pada kelompok yang diberikan keperawatan akupuntur
selama empat minggu. Sehingga dapat disimpulkan bahwa terapi akupuntur
efektif untuk mengatasi masalah insomnia.

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BAB 5. PENUTUP

5.1 Kesimpulan
Kesimpulan dari evidence based adalah :
1. Insomnia primer adalah kesulitan tidur setiap hari, penyebabnya bukan karena
gangguan tidur lain, gangguan mental atau dampak fisiologis dari zat atau
kondisi medis.
2. Akupuntur adalah cara pengobatan dengan menusukkan jarum pada titik-titik
tertentu di kulit untuk menghilangkan nyeri dan mengobati kesehatan tertentu.
3. Manfaat dari akupuntur adalah menyeimbangkan tubuh dan mengembalikan
fungsi fisiologis dengan memasukkan jarum tipis didaerah tertentu / akupoint.
Intervensi akupuntur dapat meningkatkan kandungan serotonin, asam
aminobutryic dan mengurangi kadar glutamate. Manfaat dari serotonin sendiri
dapat meningktakan mood individu.
4. Pengobatan akupuntur selama 4 minggu selama 30 menit tiap intervensi dapat
meningkatkan kualitas tidur pasien dan meningkatkan kesehatan psikologis pada
pasien insomnia.

5.2 Saran
Pembahasan terkait terapi komplementer akupuntur untuk pasien insomnia
diatas diharapkan mahasiswa keperawatan dan petugas kesehatan khususnya
perawat dapat memahami sekaligus dapat mengaplikasikan terkait penanganan
pasien insomnia tanpa menggunakan obat-obatan. Karena terapi akupuntur ini
relative murah, efisien dan aman jika dilakukan oleh orang yang sudah terlatih.
Terutamanya tugas perawat yang harus bisa menguasai terapi komplementer,
termasuk akupuntur

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DAFTAR PUSTAKA

Han, K. H., S. Y. Kim dan S. Y. Chung. 2014. Effect Of Acupuncture On Patients


With Insomnia : Study Protocol For A Randomized Controlled Trial.
Trials Journal. 15 : 403
https://www.ncbi.nlm.nih.gov/pubmed/25342100 [Diakses pada 29
Maret 2019]

Hidayat, I. T., A. Srilestari., C. Simadibrata dan J. S. Purba. 2015. Pengaruh


Akupuntur pergelangan tangan dan kaki terhadap nyeri punggung bawah.
3(2) : 95-100 https://media.neliti.com/media/publications/60849-none-
e3d1e132.pdf [Diakses pada 31 Maret 2019]

Rodin, S. S., L. Broch., D. Buysee., C. Dorsey dan M. Sateia. 2017. Clinical


Guideline for the Evaluation and Management of Chronic Insomnia in
Adults. Journal of Clinical Sleep Medicine. 4(5) : 487-504
https://aasm.org/resources/clinicalguidelines/040515.pdf [Diakses pada
31 Maret 2019]

Singh, P. 2016. Insomnia : A Sleep Disorder : Its Causes, Symptoms And


Treatments. International Journal of Medical and Health Research.
2(10) : 37 http://www.medicalsciencejournal.com/download/254/2-11-
30-126.pdf [Diakses pada 31 Maret 2019]

The American Academy of Sleep Medicine. 2008. Insomnia.


https://aasm.org/resources/factsheets/insomnia.pdf [Diakses pada 31
Maret 2019]

Yeung, W. F., F. Y. Y. Ho., K. F. Chung., Z. J. Zhang., B. Y. M. Yu., L. K. P.


Suen., L. Y. T. Chan., H. Y. Chen., L. M. Ho dan L. X. Lao. 2018. Self-
Administered Acupressure For Insomnia Disorder: A Pilot Randomized
Controlled Trial. Journal Sleep Research. 27 : 220-231
https://www.ncbi.nlm.nih.gov/pubmed/28884877 [Diakses pada 31
Maret 2019]

Yin, X., M. Gou., J. Xu., B. Dong., P. Yin., F. Masquelin., J. Wu., L. Lao dan S.
Xu. 2017. Efficacy And Safety Of Acupuncture Treatment On Primary
Insomnia: A Randomized Controlled Trial. Sleep Medicine. 37 : 193-200
https://www.sciencedirect.com/science/article/pii/S138994571730093X?
via%3Dihub [Diakses pada 29 Maret 2019]
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Sleep Medicine 37 (2017) 193e200

Contents lists available at ScienceDirect

Sleep Medicine
journal homepage: www.elsevier.com/locate/sleep

Original Article

Efficacy and safety of acupuncture treatment on primary insomnia:


a randomized controlled trial
Xuan Yin a, 1, Minghui Gou b, 1, Jian Xu a, Bo Dong a, Ping Yin a, Fernand Masquelin a,
Junyi Wu a, Lixing Lao c, d, **, Shifen Xu a, *
a
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
b
Beijing Fengtai Hospital of Traditional Chinese and Western Medicine, Beijing, China
c
University of Maryland School of Medicine, Baltimore, MD, USA
d
School of Chinese Medicine, The University of Hong Kong, Hong Kong

a r t i c l e i n f o a b s t r a c t

Article history: Objective: The objective of this study was to evaluate the efficacy and safety of acupuncture treatment for
Received 23 September 2016 primary insomnia.
Received in revised form Methods: We conducted a single-center, single-blinded, and randomized controlled clinical trial.
19 December 2016
Seventy-two patients with primary insomnia were randomly assigned into two groups e the acupunc-
Accepted 6 February 2017
Available online 8 March 2017
ture group, who received acupuncture treatment, and the control group, who received sham acupuncture
treatment. The treatment was given three times a week for four weeks. Patients were asked to wear sleep
monitors and complete questionnaires every two weeks for a total of eight weeks. The primary outcome
Keywords:
Acupuncture
was the Insomnia Severity Index (ISI). The secondary outcomes were sleep parameters including sleep
Primary insomnia efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the Actigraphy, as well as
RCT scores of the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS).
ISI Results: Compared with pretreatment baseline, patients in both groups had varying degrees of im-
Actigraphy provements in their sleep conditions. Paired t-test showed that there was a significant difference in all
indicators in the acupuncture group before and after acupuncture treatment. One-way analysis of
covariance adjusted for baseline scores indicated that the ISI improved dramatically in the acupuncture
group at two weeks post-treatment (F ¼ 11.3, p ¼ 0.001), four weeks post-treatment (F ¼ 33.6, p < 0.001),
2 weeks follow-up (F ¼ 39.4, p < 0.001) and four weeks follow-up (F ¼ 34.1, p < 0.001). Similar significant
improvements can also be observed in the SE, TST and SDS scores. Although no differences in SA and SAS
were shown between the two groups until the end of the treatment, remarkable decrements in SA and
SAS were found in the acupuncture treatment group after the two-week and four-week follow-ups.
Conclusion: Acupuncture treatment is more effective than sham acupuncture treatment in increasing
insomnia patients' sleep quality and improving their psychological health.
Trial Registration: Chinese Clinical Trial Registry: Chi CTR-TRC-14004859.
© 2017 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

1. Introduction presence of another sleep disorder, mental disorder, or as the direct


physiological effect of a substance or medical condition [1]. Primary
Insomnia is a great challenge to the physical and mental health insomnia is usually caused by sleep initiation or maintenance dis-
of individuals. Primary insomnia (PI) is commonly defined as sleep orders, including difficulty in falling asleep, dreaminess, and rest-
difficulties that affect daytime functioning; it does not occur in the less sleep [2]. The incidence of insomnia is increasing in the world;
about 23.2% of the adult population in the United States suffer from
insomnia [3]. Moreover, the incidence rate of insomnia in the
* Corresponding author. Shanghai Municipal Hospital of Traditional Chinese Chinese population is up to 45.4% [4]. Sleep disorders are consid-
Medicine, No. 274 Middle Zhijiang Road, 200071, Shanghai, China. ered to be closely related to fatigue, decreased alertness and con-
** Corresponding author. The University of Hong Kong, Pokfulam, Hong Kong.
centration disturbances, etc. [5e7]. Clinical epidemiological studies
Fax: þ852 28582549.
E-mail addresses: lxlao1@hku.hk (L. Lao), xu_teacher2006@126.com (S. Xu). have also suggested that insomnia is a risk factor for hypertension
1
These authors contributed equally to this work. [8], stroke [9], mental disorders, including anxiety and depression

http://dx.doi.org/10.1016/j.sleep.2017.02.012
1389-9457/© 2017 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
194 X. Yin et al. / Sleep Medicine 37 (2017) 193e200

[10], as well as reduced human body immunity [11]. Insomnia as a Index (ISI) score was more than eight points but less than 21 points
public health problem has not received adequate recognition and and the sleep efficiency (SE) recorded by the Actigraphy (wActi-
has not been effectively resolved [12]. Sleep-BT. LLC, Pensacola, USA) was less than 85%, (5) voluntarily
Currently, the primary treatment for insomnia is psychological agreed with the investigation and signed a written informed con-
treatment complemented with medications [13]. Psychological sent form before the clinical trial started.
treatment mainly refers to cognitive behavioral therapy (CBT) for The exclusion criteria were as follows: (1) the patient had
insomnia, which has been proven to be efficient but is still inade- serious cardiovascular, liver, kidney or hematopoietic system dis-
quately available and accessible to meet the population needs [14]. ease, (2) the patient's insomnia was caused by nervous system
Benzodiazepines, barbiturates and other sedatives are the first-line disease (eg, stroke, Parkinson's Disease), (3) the patient's insomnia
pharmacological treatment for primary insomnia [15]. Despite their was caused by mental disorders including depression or anxiety,
short-term efficacy for symptomatic relief, long-term use of these (4) the patient had a history of sleep apnea, (5) the patient was a
medications may cause residual symptoms such as excessive pregnant or lactating woman, (6) the patient had taken antide-
sedation, tolerance, addiction and neurological toxicity [16,17]. pressant drugs or antipsychotic drugs two weeks before the trial,
Acupuncture is one of the most popular and safest therapies; it (7) the patient did not want to take the Actigraphy.
has been used to treat primary insomnia since antiquity in China.
Acupuncture balances the body and restores its physiological 2.3. Sample size calculation
function by inserting thin needles at specific acupoints. Therefore,
it does not affect the natural sleepewake cycle. It is found that Referring to the previous trial on electro-acupuncture for pri-
acupuncture can increase the content of serotonin and amino- mary insomnia published in Sleep [26], we determined that a
butyric acid [18], and reduce glutamate levels [19]. Thus, sample size of 30 in each group would provide a power of 80% and
acupuncture treatment can improve the function of central inhi- an alpha level of 0.05 allowing us to detect the difference in ISI
bition and help people sleep [20]. score between the two groups. Allowing a 20% dropout rate, a
However, many of the relevant studies seem far less compelling sample size of 36 in each group was needed in this trial.
due to some important limitations, including imperfections in
design, poor quality of primary studies and lack of objective sleep 2.4. Randomization and allocation
assessments [21]. Their results are far from uniform and fail to
arrive at a positive verdict about the effectiveness of acupuncture Patients who were interested in participating in the trial were
[22]. Therefore, it is important to implement high-quality ran- initially screened by phone and then were asked to do a face-to-
domized controlled trials (RCTs) of acupuncture treatment for face interview to conduct further surveys. After recruiting all the
insomnia, with appropriate sham acupuncture and blind method. participants, a random number table was generated to divide the
To address some design defects and logic problems of acupuncture participants into two groups in a ratio of 1:1 using the statistical
research, we designed a randomized, parallel-group, and single- software SPSS20.0. Randomization numbers were sealed in opaque
blinded clinical trial with a one-month treatment period and a envelopes, with patients' screening sequence numbers printed
one-month follow-up period. outside. All envelopes were numbered consecutively. Another
In this study, we aim to observe the therapeutic effect of researcher, who screened the eligible patients after baseline,
acupuncture treatment on primary insomnia and try to eliminate opened the envelopes and then assigned the patients to either the
the placebo effect of acupuncture by setting up a control group with treatment group or the control group.
reasonable placebo conditions.
2.5. Blinding
2. Methods
Participants were not aware of their group assignments in the
2.1. Design trial. Researchers including statisticians, outcome assessors and
data analysts were all blinded to the patients' group assignments as
This is a patient-assessor-blinded, randomized and sham well. Although acupuncturists were not blinded to the group as-
controlled trial. Outcome measurements were assessed at baseline, signments, they were not involved in the outcome assessments or
two weeks post-treatment, four weeks post-treatment, two weeks data analyses. Participants were asked to wear an eye mask to get a
follow-up and four weeks follow-up. On June 2014, the protocol good rest and a better therapeutic effect. To validate the successful
was approved by the ethics committee of Shanghai Municipal implementation of the blinding method, we conducted each
Hospital of Traditional Chinese Medicine. We followed the treatment in a closed unit with the use of screen separation. The
Consolidated Standards of Reporting Trials (CONSORT) and Stan- same needle tubes, acupoints and skin disinfection process were
dards for Reporting Interventions in Clinical Trials of Acupuncture used for both the real and sham acupuncture groups. In addition, all
(STRICTA) guidelines for designing and reporting controlled trials researchers had accepted training for the specific operation before
[23,24]. the trial started. They were asked to strictly adhere to the separa-
tion principle.
2.2. Participants and recruitment
2.6. Intervention
The patients were recruited by hospital-based advertisements
from the outpatient clinic and the website of Shanghai Municipal The intervention began on the day after the randomization
Hospital of Traditional Chinese Medicine (TCM) from September finished. All participants received 12 treatments (three times a
2014 until January 2015. week for four weeks). Treatments were performed after skin
The inclusion criteria were as follows: (1) aged 18e65 years, (2) disinfection with 75% alcohol. Patients were asked to lie supine,
met the diagnostic criteria of insomnia according to the Diagnostic wearing eye masks for better curative effect. Each participant
and Statistical Manual of Mental Disorders (Fourth Edition, DSM- received acupuncture treatment by the same acupuncturist who
IV) [25], (3) experienced insomnia for more than a month but had more than five years of clinical experience in acupuncture
less than 2 years before the trial started, (4) the Insomnia Severity therapy. The temperature of the treatment room could not be lower
X. Yin et al. / Sleep Medicine 37 (2017) 193e200 195

Table 1 2.7. Quality control


Acupuncture method for each acupoint.

No. Acupoint Needling method Needles The trial was conducted under the supervision of two de-
1 Baihui (GV20) The angle between the needle tip and 0.3*40 mm
partments, Shanghai Municipal Hospital of Traditional Chinese
the scalp is 30 . Move the needle tip Medicine and Shanghai Academy of Education Science. Researchers
backward along the anterioreposterior inputted the collected data immediately on the ResMan website.
midline, and then insert the needle 0.5 The Clinical Research Center of Drugs of Shanghai University of TCM
cun.
worked as the data monitoring team to identify problems during
2 Shenting (GV24) The angle between the needle tip and 0.3*25 mm
the scalp is 30 . Move the needle tip the trial, examine collected data, and control bias. Meanwhile, a
backward along the anterioreposterior qualified clinical trial expert was invited to monitor the study.
midline, and then insert the needle 0.5
cun.
2.8. Outcome measures
3 Yintang (GV29) Pinch the local skin, and then puncture 0.3*25 mm
obliquely 0.5 cun
4 Anmian (EX-HN22) The angle between the needle tip and 0.3*40 mm 2.8.1. Primary outcome
the scalp is 30 . Puncture ISI: ISI is a reliable and valid instrument to detect cases of
perpendicularly 0.5 cun with the needle insomnia and is sensitive to treatment response in clinical patients
tip pointed toward the nose tip
[27]. According to the results, 0e7 points indicates insomnia
5 Shenmen (HT7) Puncture perpendicularly 0.5 cun. 0.3*25 mm
6 SanYinjiao (SP6) Puncture perpendicularly 1e1.5 cun. 0.3*40 mm without clinical significance; 8e14 points indicates mild insomnia;
15e21 points indicates moderate insomnia; 22e28 points indicates
1 cun ¼ 25 mm.
severe insomnia.

2.8.2. Secondary outcomes


than 25  C. Patients were allowed to take orally 0.5e2 mg of the 2.8.2.1. Objective sleep quality measured by the wActiSleep-BT
sedative-hypnotic medicine, Estazolam (Approval number: monitor. The Actigraphy is a small-sized wrist watch worn on a
H31021534, Shanghai Xinyi Medicine Co., Ltd) when they found it patient's wrist, monitoring his or her sleep quality, including sleep
extremely difficult to fall asleep. onset, sleep latency, the number of awakenings during the night,
duration of sleep, etc. The main sleep parameters are SE, total sleep
2.6.1. Acupuncture group time (TST) and sleep awakenings (SA).
Patients in the acupuncture group received acupuncture treat-
ment on Baihui (GV20), Shenting (GV24), Yintang (GV29), bilateral 2.8.2.2. Self-Rating Anxiety Scale (SAS). The main indicator is the
Anmian (EX-HN22), bilateral Shenmen (HT7), and bilateral total score. The sum of 20 items, a score of more than 40 points
Sanyinjiao (SP6). Tube-guided acupuncture needles were inserted illustrates anxiety; the greater score indicates the higher degree of
to a depth of 17e25 mm at each acupoint. After insertion, rotating anxiety.
manipulation or lifting-thrusting manipulation was applied for
‘deqi’ sensation (Table 1 and Fig. 1). Each acupuncture treatment 2.8.2.3. Self-rating Depression Scale (SDS). The total score is the
lasted 30 min. main statistical indicator. We calculated the standard score first,
1.25 multiplied by the raw score (the sum of 20 questions). We then
2.6.2. Control group rounded to the nearest integer to calculate the total score. The
The major difference between the interventions for the two dividing point of the depression judgment is 50 points; the higher
groups was the tube needling method. Otherwise, the procedure the score is, the more significant the depressive tendency is.
was the same as that performed in the acupuncture group. There
was no needle in the tube when performing treatments for patients 2.8.2.4. Estazolam dose. Patients were asked to inform the assess-
in the control group. The acupuncturist placed the tube close to the ment researcher and record the dose and the time of taking Esta-
skin at the acupoint, and then tapped the top of the tube in order to zolam on the case report form (CRF) table.
give patients the sensation of a ‘real’ needle being inserted into the
body. Each treatment also lasted 30 min. At the end of the treat- 2.9. Statistical analysis
ment, the acupuncturist also used a dry cotton ball to press the
acupoints so that patients could feel the withdrawal of ‘real’ All analyses were performed on the intention-to-treat (ITT)
needles. population of participants who had at least one treatment. Missing

Fig. 1. Location of acupoints.


196 X. Yin et al. / Sleep Medicine 37 (2017) 193e200

data were replaced according to the principle of the last observa- about the long duration of weekly participation; eight had
tion carried forward. Data analyses were performed with the use of depression or other sleep disorders; 18 had other reasons to refuse
the statistical software R version 3.1.0. The t-test was used to participation). The other 94 participants were asked to come to the
compare the measurement data between the two groups from the acupuncture outpatient clinic where they were requested to un-
baseline to the fourth week follow-up; rank sum test was used for dergo further screening. Twenty-two participants were excluded
ranked data while c2 test was adopted to analyze categorical data. A during the face-to-face screening (six failed to meet the ISI or SE
one-way analysis of covariance (ANCOVA) with the baseline mea- criteria and 16 dropped out before randomization). As a conse-
surement as the covariate was used to investigate differences be- quence, 72 participants were recruited and randomly assigned to
tween the acupuncture and sham acupuncture group at post- two groups. A total of 10 participants dropped out during the eight-
treatment and follow-up. The significance level used for statistical week study period (three went abroad for personal reasons, four
analysis with two-tailed testing was 5%. Data values were mainly went on business trips during the treatment period for more than 1
presented as mean ± SD. week, and three asked for other medication treatment due to the
unsatisfactory effect of their acupuncture treatment). There were
3. Results no missing data in the remaining 62 participants who completed
the study. None of the participants withdrew due to adverse events.
3.1. Number of participants
3.2. Demographic and clinical characteristics
A total of 137 participants were recruited in initial recruitment
(Fig. 2). When the researcher contacted them to perform pre- Baseline features of the two groups are presented in Table 2.
liminary screening by phone, 43 participants were excluded (four There were no significant differences identified in demographic
were older than 65 years old; 13 refused to participate when told and clinical characteristics between the two groups (p > 0.05)

Fig. 2. Participant flowchart. ISI, Insomnia Severity Index; SE, sleep efficiency.
X. Yin et al. / Sleep Medicine 37 (2017) 193e200 197

Table 2
Demographic and clinical characteristics of the intention-to-treat population.

Variables Acupuncture group (N ¼ 36) Control group (N ¼ 36) p

Age (years) 39.7 ± 12.9 37.3 ± 15.1 0.163*


Gender (male/female) 17/19 15/21 0.608*
Education attainment (years) 16.4 ± 3.3 14.8 ± 3.9 0.483*
Marital status 0.621*
Never married 9 (25.0) 12 (33.3)
Married 22 (61.1) 21 (58.3)
Divorced/widowed 5 (13.9) 3 (8.3)
Alcohol use 4 (11.1) 1 (2.8) 0.179*
Cigarette use 3 (8.3) 1 (2.8) 0.296*
ISI total score 17.1 ± 4.1 17.0 ± 4.5 0.798*
SE (%) 74.4 ± 14.8 74.9 ± 8.8 0.165*
TST (min) 334.5 ± 69.6 282.4 ± 69.3 0.003
SA 20.1 ± 7.4 22.6 ± 7.6 0.460*
SAS total score 44.0 ± 8.0 48.4 ± 8.0 0.011
SDS total score 47.3 ± 10.4 48.6 ± 11.1 0.381*

Data were presented as mean ± SD. ISI, Insomnia Severity Index; SA, Sleep Awakenings; SAS, Self-Rating Anxiety Scale; SD, standard deviation; SDS, Self-Rating Depression
Scale; SE, Sleep Efficiency; TST, Total Sleep Time.
*p > 0.05.

except for the TST and SAS score. The TST was higher and the SAS p < 0.001) and 4 weeks follow-up (F ¼ 20.2, P < 0.001), the par-
score was lower in the acupuncture group. ticipants' SA in the acupuncture group were significantly lower
than those in the sham acupuncture group. The TST in the
3.3. Outcomes acupuncture group showed significantly greater improvement at all
four observation points (all p < 0.01).
3.3.1. Sleep quality
The one-way ANCOVA analytic method adjusted for baseline 3.3.2. Psychological health
characteristics was used in the published study to investigate dif- Table 5 shows the SDS and SAS scores of the two groups. One-
ferences between groups and prove certain feasibility [26]. The way ANCOVA adjusted for baseline scores showed there was a
results of our study showed that there was significant between- significant difference in between-group SDS and SAS scores. Paired
group variation in ISI score, SE, SA and TST (Tables 3 and 4). t-test for SDS and SAS in the acupuncture group indicated that there
Outcome analysis showed that there was a remarkable decrease in were significant differences in these scores before and after
ISI total score in both groups. acupuncture treatment (all p < 0.05). The results suggested that
Results of paired t-test for the ISI score in the acupuncture group acupuncture could effectively improve the insomnia patients'
showed that there was significant difference before and after mental state. Participants in both groups had lower SDS and SAS
intervention (all p < 0.01), indicating that the ISI score of patients scores than baseline. Compared with the control group, the
with primary insomnia was significantly improved after receiving acupuncture group showed significant reduction in SDS at two
acupuncture treatment. Similar results could also be observed in weeks post-treatment (F ¼ 7.7, p ¼ 0.007), four weeks post-
SE, SA and TST in the acupuncture group. Compared with the treatment (F ¼ 13.0, p ¼ 0.001), 2 weeks follow-up (F ¼ 9.6,
control group, the acupuncture group showed significant reduction p ¼ 0.003) and four weeks follow-up (F ¼ 5.9, p ¼ 0.018). There
in ISI score at 2 weeks post-treatment (F ¼ 11.3, p ¼ 0.001), four were no significant differences in SAS scores between the two
weeks post-treatment (F ¼ 33.6, p < 0.001) and two weeks follow- groups at two weeks post-treatment (F ¼ 0.24, p ¼ 0.627); the
up (F ¼ 39.4, p < 0.001) and four weeks follow-up (F ¼ 34.1, remarkable between-group differences were found at four weeks
p < 0.001). Participants in the acupuncture group had significantly post-treatment (F ¼ 25.5, p < 0.001), two weeks follow-up (F ¼ 12.7,
higher SE recorded by the Actigraphy at two weeks post-treatment p ¼ 0.001) and four weeks follow-up (F ¼ 6.8, p ¼ 0.011).
(F ¼ 4.6, p ¼ 0.036), four weeks post-treatment (F ¼ 27.0, p < 0.001),
two weeks follow-up (F ¼ 29.0, p < 0.001) and four weeks follow- 3.3.3. Adverse effect and medication
up (F ¼ 22.1, p < 0.001) than those receiving sham acupuncture One participant in the acupuncture group suffered local hema-
treatment. No between-group difference in SA was found at two toma and another complained of headache during the trial. Par-
weeks post-treatment (F ¼ 0.22, p ¼ 0.888). At four weeks post- ticipants in the control group reported no adverse events. The
treatment (F ¼ 30.5, p < 0.001), 2 weeks follow-up (F ¼ 30.0, patient with local hematoma was treated with cold compress and

Table 3
Changes in Insomnia Severity Index of two groups from 2 weeks post-treatment to 4 weeks follow-up.

Acupuncture group Control group ANCOVA F ANCOVA p

Mean SD 95% CI Paired t-test p Mean SD

ISI
Baseline 17.1 4.1 17.0 4.5
2 weeks post-treatment 13.4 3.9 4.40, 0.88 0.004** 16.0 4.3 11.3 0.001**
4 weeks post-treatment 10.5 3.8 6.86, 3.08 <0.001** 15.5 4.3 33.6 <0.001**
2 weeks follow-up 9.9 4.1 6.82, 3.79 <0.001** 15.2 4.1 39.4 <0.001**
4 weeks follow-up 9.6 4.2 6.32, 3.45 <0.001** 14.4 3.8 34.1 <0.001**

Data were presented as mean ± SD. ANCOVA, one-way analysis of covariance; CI, confidence interval; ISI, Insomnia Severity Index; SD, standard deviation.
*p < 0.05; **p < 0.01.
198 X. Yin et al. / Sleep Medicine 37 (2017) 193e200

Table 4
Changes in sleep efficiency, sleep awakenings and total sleep time of two groups from 2 weeks post-treatment to 4 weeks follow-up.

Acupuncture group Control group ANCOVA F ANCOVA p

Mean SD 95% CI Paired t-test p Mean SD

SE
Baseline 74.4 14.8 74.9 8.8
2 weeks post-treatment 82.0 8.5 0.73,8.34 0.098 78.2 9.8 4.6 0.036*
4 weeks post-treatment 89.3 8.2 6.13,14.54 <0.001** 79.0 9.4 27.0 <0.001**
2 weeks follow-up 89.1 8.0 6.83,16.12 <0.001** 77.6 10.9 29.0 <0.001**
4 weeks follow-up 87.0 8.5 5.72,15.28 <0.001** 76.4 11.1 22.1 <0.001**
SA
Baseline 20.1 7.4 22.6 7.6
2 weeks post-treatment 18.5 7.6 4.91,1.85 0.37 20.0 7.4 0.02 0.888
4 weeks post-treatment 10.2 6.8 12.22,6.39 <0.001** 19.5 7.5 30.5 <0.001**
2 weeks follow-up 10.8 6.6 11.78,5.95 <0.001** 19.6 7.3 30.0 <0.001**
4 weeks follow-up 11.3 7.3 10.76,4.85 <0.001** 19.1 6.9 20.2 <0.001**
TST
Baseline 334.5 69.6 282.4 69.3
2 weeks post-treatment 361.2 65.2 43.35,110.93 <0.001** 284.0 80.7 8.1 0.006**
4 weeks post-treatment 397.3 55.3 85.63,142.43 <0.001** 283.3 63.7 49.8 <0.001**
2 weeks follow-up 393.4 53.0 51.54,131.40 <0.001** 301.9 108.4 10.6 0.002**
4 weeks follow-up 385.9 55.4 69.06,137.94 <0.001** 282.4 79.7 25.8 <0.001**

Data were presented as Mean ± SD; *p < 0.05; **p < 0.01; CI, confidence interval; SA, sleep awakenings; SD, standard deviation; SE, sleep efficiency; TST, total sleep time.

Table 5
Changes in SDS, SAS of two groups from 2 weeks post-treatment to 4 weeks follow-up.

Acupuncture group Control group ANCOVA F ANCOVA p

Mean SD 95% CI Paired t-test p Mean SD

SDS
Baseline 47.3 10.4 48.6 11.1
2 weeks post-treatment 43.4 9.8 9.70, 0.63 0.027* 48.6 9.5 7.7 0.007**
4 weeks post-treatment 37.3 9.9 12.41, 3.48 <0.001** 46.6 11.5 13.0 0.001**
2 weeks follow-up 38.8 8.0 10.5, 2.22 0.004** 46.0 11.3 9.6 0.003**
4 weeks follow-up 39.7 9.5 10.68, 1.32 0.013* 45.4 14.5 5.9 0.018*
SAS
Baseline 44.0 8.0 48.4 8.0
2 weeks post-treatment 41.7 10.5 8.42, 0.36 0.034* 46.1 7.9 0.24 0.627
4 weeks post-treatment 35.6 6.3 12.83, 6.95 <0.001** 45.5 7.8 25.5 <0.001**
2 weeks follow-up 36.3 6.2 12.04, 4.90 <0.001** 44.7 9.2 12.7 0.001**
4 weeks follow-up 35.9 7.2 11.33, 3.56 <0.001** 43.4 9.6 6.8 0.011*

Data were presented as mean ± SD. ANCOVA, one-way analysis of covariance; CI, confidence interval; SAS, Self-Rating Anxiety Scale; SD, standard deviation; SDS, Self-Rating
Depression Scale.
*p < 0.05; **p < 0.01.

recovered in three days; the patient with headache was told to rest treatment period to the follow-up period. The control group with
and she felt better the next day. Neither of them quit the trial. There the proper sham acupuncture operation method was set to elimi-
was no statistical significance in the incidence of adverse events nate the placebo effect of acupuncture. As expected, the better ef-
between two groups (p ¼ 0.164 > 0.05). No participant in either fect of acupuncture over placebo provided strong evidence against
group was reported to take Estazolam for insomnia during the trial. the misunderstanding that acupuncture is a placebo therapy and
has no real effect [28].
4. Discussion Primary insomnia is a chronic and recurrent disease with mul-
tiple factors [2]. Studies reported that depression and anxiety
In this study, we conducted a strictly randomized, controlled symptoms may manifest prior to and increase risk for the devel-
research to observe the effect and safety of acupuncture for primary opment of adult insomnia [29,30]. Acupuncture is considered to
insomnia and to overcome some methodological challenges in have a unique advantage not only in improving sleep disorders, but
present clinical researches of acupuncture. also in regulating a healthy mental state. Our results implied that
According to the results, acupuncture can improve insomnia acupuncture had antidepressive effects for insomnia patients. These
patients' SE, prolong TST, improve insomnia severity, and relieve findings may also have implications for the etiology of insomnia and
depressive or anxious moods. There was no severe adverse effect the therapeutic mechanism of acupuncture for insomnia.
reported during the trial. It is suggested that acupuncture treat- The number of RCT studies on insomnia by acupuncture treat-
ment can be safely applied in insomnia treatment. It is also indi- ment increases every year, but their results remain heterogeneous
cated that acupuncture treatment was more effective than sham due to the stagnant methodology quality. Some previous studies
acupuncture treatment in improving insomnia patients' sleep suggested that the effect of acupuncture for insomnia was equal or
quality and psychological health. Compared to the control group, a little superior to sham acupuncture [31]. These studies tend to
improvements in ISI, SDS, SAS and sleep quality recorded by the have short treatment duration; most of them were less than four
Actigraphy of the acupuncture group were more significant. Dif- weeks. They did not follow up for a long time to assess any lasting
ferences between the two groups were well maintained from the effects of acupuncture. Besides, few of them selected the acupoints
X. Yin et al. / Sleep Medicine 37 (2017) 193e200 199

based on syndrome differentiation. Almost none of them put Conflict of interest


emphasis on the experienced acupuncturists' manipulation for
‘deqi’ sensation. In our study, we tried to readdress these problems The authors declare that they have no competing interests.
and achieve positive results with acupuncture treatment, helping The ICMJE Uniform Disclosure Form for Potential Conflicts of
to emphasize that acupuncture is far more effective than placebo Interest associated with this article can be viewed by clicking on the
treatment. We designed a four-week treatment duration with a following link: http://dx.doi.org/10.1016/j.sleep.2017.02.012.
four-week follow-up period to evaluate and compare the thera-
peutic and lasting effects of acupuncture and sham acupuncture on
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Han et al. Trials 2014, 15:403

TRIALS
http://www.trialsjournal.com/content/15/1/403

STUDY PROTOCOL Open Access

Effect of acupuncture on patients with insomnia:


study protocol for a randomized controlled trial
Kyung-Hun Han1, Sang-Young Kim2 and Sun-Yong Chung2*

Abstract
Background: Hypnotic drugs tend to be the dominant form of treatment of insomnia, but these come with a
number of reported side effects. Acupuncture has been studied as an alternative, resulting in a rising need for
methodological research towards verifying its efficacy as insomnia treatment.
Methods/Design: We describe a proposal for a single-center, patient-assessor-blinded, randomized controlled trial
with two parallel arms. A total of 38 patients complete screening tests at the first visit, are registered into the clinical
trial, and then randomly assigned to the experimental or sham control groups (19 patients for each group). All
subjects are clinical insomnia patients who score a 6 or above on the Pittsburgh Sleep Quality Index (PSQI) and
meet all inclusion criteria. All subjects are treated with acupuncture and intradermal acupuncture (IDA) three times
during the first week. Five sham acupoints are used in the control group. In the experimental group, five real
acupoints (PC6, SP6, HT7, KI6, and BL62) are used unilaterally in turn. Sham acupoints are over 1 cm away from each
real acupoint.
The primary outcomes are the scores on the Insomnia Severity Index (ISI) and PSQI. Secondary outcomes are
the sleep log, the Beck Depression Inventory (BDI), the State-Trait Anxiety Inventory (STAI), the World Health
Organization Quality of Life Abbreviated Version (WHOQOL-BREF), the Korean-Auditory Verbal Learning Test
(K-AVLT), the Digit Span Test (DS), Event Related Potentials (ERPs) and heart rate variability (HRV) to assess emotional
states, sleep quality, cognitive functioning, and electro-physiological changes.
Subjects are assessed at three time points: baseline, post-treatment and follow-up. The duration of the clinical trial
is 18 days.
Discussion: To study the enhancement of the effectiveness of acupuncture for insomnia, we test the intradermal
acupuncture method, which is performed continuously on the subject’s skin and stimulated at home by the subject
every night. In the trial, objective measurements including ERPs and HRV are used to evaluate states of cognition
and autonomic nervous system functioning and subjective self-report questionnaires assess insomnia symptoms.
‘Sham’ acupuncture points provided by STRICTA are used for the control group.
Trial registration: ClinicalTrials.gov: NCT01956760, registered 5 September 2013.
Keywords: Insomnia, Acupuncture, Intradermal acupuncture, Clinical trial

* Correspondence: lovepwr@khu.ac.kr
2
Department of Hwabyung/Stress Clinic, Kyung Hee University Korean
Medicine Hospital at Gangdong, 149, Sangil-Dong, Gangdong-gu, Seoul,
Korea
Full list of author information is available at the end of the article

© 2014 Han et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
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Background for future trials to provide more methodologically sound


Insomnia is commonly defined as a state of being disturbed evidence of acupuncture’s effect.
during daytime activities due to poor sleep quality caused It is also is important to include an assessment of
by difficulties in sleep initiation or maintenance despite psychological/mood states, cognitive functions, and physio-
being in a proper sleep-inducing environment. According logical states in future evaluations. According to the diag-
to the International Classification of Sleep Disorders, nostic criteria of insomnia defined by the Diagnostic and
Second Edition (ISDC-2), insomnia can be categorized as Statistical Manual of Mental Disorders, Fourth Edition
acute insomnia, inadequate sleep hygiene, psychophy- (DSM-IV), insomnia is related to anxiety and depression,
siological insomnia (primary insomnia), idiopathic insom- with many previous neuropsychological studies reporting
nia, paradoxical insomnia, and insomnia associated with a that lack of sleep may lead to learning-memory dis-
medical condition [1]. Approximately 35% of adults ex- turbances, low attention with a descending level of
perience insomnia at least once in their lives and almost concentration, and mood changes [13]. Regarding the
half suffer seriously. Several studies report that approxi- pathophysiology of insomnia, several studies show that
mately 10% of adults are disrupted in their daily activities beta electroencephalogram (EEG) activities increase while
due to chronic insomnia [2,3]. alpha EEG activities decrease in patients with insomnia
Benzodiazepines, nonbenzodiazepine sedatives, and [14]. Other studies observed decreasing beta EEG activ-
melatonin agonists are the primary pharmacological ities in patients with insomnia after cognitive behavior
treatments for insomnia. Secondary treatment includes therapy or treatment [15]. Some studies of Event Related
antidepressants, diphenhydramine, antipsychotics, and Potentials (ERPs) report increasing N1 amplitude and de-
barbiturates [4]. Although effective, these medications creasing N350 amplitude in insomnia patients compared
often cause side effects such as residual daytime seda- to controls; these ERPs’ components are related to hyper-
tion, drowsiness, dizziness, lightheadedness, cognitive arousal and inhibition or regulation of arousal [16,17].
impairment, motor incoordination, and dependence [5]. Additionally, a recent study shows that HF (high fre-
The current most prevalent non-pharmacological the- quency) in heart rate variability (HRV) is more dominant
rapies for insomnia are sleep hygiene education [6] and than LF (low frequency) in patients with insomnia [18].
cognitive and behavioral psychotherapy, but such treat- However, according to one review, there are no consistent
ments require long-term implementation [7]. results of HRV in studies of effect in acupuncture treat-
The effect of acupuncture on insomnia is consistently ment, although HRV is a useful tool for observing how
emerging as an alternative treatment for insomnia. In a acupuncture treatment affects the autonomic nervous sys-
systematic review by Yeung et al., 20 randomized con- tem related to sleep cycles [19].
trolled trials were analyzed to assess the effect of acu- Furthermore, relying on self-report measures - which
puncture on insomnia patients by comparing them with are subjective and vulnerable to biases - to verify symp-
control patients given a benzodiazepine, with results in- tom reporting is inadequate. Changes in psychological,
dicating that acupuncture was more effective. The study, physiological, and cognitive functions should be ob-
however, has certain limitations including an undefined served using more objective methods, such as neuro-
criterion for diagnosis, lack of randomization or blinded psychological tests and electro-physiological measures.
conditions, and small sample sizes [8]. Several other
studies investigate the effect on acupuncture as a treat- Methods/Design
ment for insomnia by comparing different acupuncture Hypothesis
therapies, the effects of using and not using moxa, and Insomnia patients treated with acupuncture therapy
comparison with placebo sleeping pills [9-11]. One of would have their symptoms more effectively relieved
these studies shows that auricular acupuncture therapy than patients in a sham control group.
is more effective for insomnia than two other therapies,
and another suggests that acupuncture therapy with Objectives
moxa is more effective than without [9,10]. Cheuk et al.,
in a review of 33 clinical trials on the effects of acupunc- 1) To examine significant improvement in the
ture on insomnia, conclude that many trials indicate Insomnia Severity Index (ISI), the Pittsburgh Sleep
acupuncture treatment improves quality of sleep, but fu- Quality Index (PSQI), and sleep logs of insomnia
ture trials need to be more methodologically rigorous, patients [20,21];
and that extant trials may be prone to the risk of bias 2) To compare changes in EEG and HRV brought on
coming from the definition of insomnia, participant by acupuncture treatment;
characteristics, acupoints, and treatment regimen [12]. 3) To compare changes on the Beck Depression
Despite the number of studies related to acupuncture Inventory (BDI), the State-Trait Anxiety Inventory
and insomnia in the literature however, it is necessary (STAI), the World Health Organization Quality of
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Life Abbreviated Version (WHOQOL-BREF), the assess the maintenance of blind conditions after the se-
Korean-Auditory Verbal Learning Test (K-AVLT), cond treatment [28].
and the Digit Span Test (DS) from pre- to Registered patients shall be randomly divided into the
post-acupuncture treatments [22-26]. experimental and sham control groups, with an equal
number of patients assigned to each group. Patients will
Setting then complete either the experimental or sham acupunc-
The study will be performed at the Hwabyung/Stress Clinic ture treatment 3 times, with 2- to 3-day intervals, within
in the Kyung Hee University East-West Neo Medical 1 week.
Center at Gangdong, Seoul, as a single-center, patient- Figure 1 is an overview of this trial, and Figure 2 is an
assessor-blinded, parallel-group randomized controlled approximate visit schedule.
trial. Subjects will be recruited through advertisements
on Internet websites, newspapers, and hospital bulletins. Participants
Subjects interested in participating in the trial shall be Inclusion criteria
assessed according to inclusion and exclusion criteria by
phone. Subjects who meet those criteria will be asked to a. Male or female over 18 under 65 years old
visit the investigation site. b. Reports clinical symptoms for insomnia and score of
At the site first visit for screening meeting, subjects 6 or above on the PSQI
will be given more detailed information about the pro- c. Demonstrates no problems with communication,
cedures of the study and asked to provide written both visual and auditory (reading, writing, hearing,
informed consent if they wish to enroll. Candidate sub- speaking, and watching)
jects will then complete the PSQI, with a score of 6 or d. Signed the written informed consent form for the
above on the PSQI being used to diagnose subjects as clinical trial
clinical insomnia patients. At this point, inclusion and
exclusion criteria will be reassessed, with patients satis-
Exclusion criteria
fying those criteria being enrolled and registered into
the clinical trial.
a. Has taken Western and/or Oriental medicine and/or
Registered patients shall be provided with a handout
dietary supplements in the past 2 weeks for
on sleep hygiene education that includes a brief account
insomnia
by the experimenter. They shall also be instructed to
b. Has a severe neural or psychiatric disorder or a
complete a sleep log for 2 days prior to their second visit
history of major neuropsychiatric disorder
to the center for the baseline evaluation and the first
(for example, autism, learning disorder, mental
treatment, in order to see whether they had experienced
retardation, and so on)
insomnia recently and could properly keep their sleep
c. Has received acupuncture for insomnia treatment in
logs. On the day of the second visit, an expert will check
the past month
whether patients have completed their sleep logs cor-
d. Has infection or inflammation at the acupoints
rectly and re-conduct them on their sleep log writing
e. Has a hemorrhagic disease or anticoagulant intake
methods if necessary. The patients will complete their
f. Has a serious physical disorder
sleep logs during 2 weeks from the second visit.
g. Has participated in any other clinical trial within a
On the second visit day for the baseline evaluation and
month of the screening date
the first treatment, all patients will also complete the
h. Pregnancy, breast-feeding, or being a woman of
PSQI, ISI, BDI, STAI, K-AVLT, and the DS, with HRV
childbearing age not on a proper method of birth
measured at baseline (prior to first treatment), after the
control
last treatment, and at the 1-week follow-up. EEG recor-
dings will be used as objective measures to validate self-
reported insomnia symptoms. ERPs will be measured at Assessments
baseline and after the last treatment using an odd-ball All assessments in the trial are shown in Figure 2.
task. Spontaneous EEGs will also be measured at base-
line after the last treatment for spectral analysis. All sub- Interventions
jects will complete the WHOQOL-BREF at baseline In the experimental group, patients will receive needle
and at 1-week follow-up. They will also complete the acupuncture treatment on 5 specified acupoints (PC6,
Temperament Character Inventory (TCI) at baseline. All SP6, HT7, KI6, and BL62) for 20 minutes. After 20 mi-
patients will also complete a sleep log every day from nutes, the needles will be removed and intradermal acu-
baseline to the 1-week follow-up [27]. The Credibility of puncture (IDA) placed at the same points. The smaller
Treatment Rating Scale (CTRS) will be administered to IDA shall be kept attached on the skin for 48 to 72 hours
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Figure 1 Study flow chart.

and all patients will be instructed to stimulate them- acupoints. The sham acupoints shall be about 1.0 cm
selves before sleep. from the real acupoints in the experimental group and
In the control group, all interventions shall be the are spots that do not belong to standard acupoints on
same as those of the experimental group except the loca- the body and are not suitable for actual acupuncture
tion of the acupoints, substituting them with five sham based on anatomical and other conditions. IDA will be
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Figure 2 Treatment and assessment schedule.

placed at five sham acupoints in the control group as baseline, post-treatment assessment, and 1-week follow-
well with the same instructions as that of the experimen- up (only the EEG was excluded at 1-week follow-up).
tal group. The BDI and STAI measure emotional states. The BDI
All acupuncture treatment complies with the Standards is a self-report scale used in clinics and research com-
for Reporting Interventions in Clinical Trials of Acupunc- monly for measuring severity of depression through a
ture (STRICTA) revised in 2010 (see Table 1) [29]. 21-item multiple-choice questionnaire. The STAI in turn
is a 40-question self-report inventory based on a 4-point
Likert scale that measures each state and trait of anxiety.
Outcomes
Normalized Korean versions of both instruments will be
Primary outcome
used in the trial. The WHOQOL-BREF will be used for
The primary outcome of this study will be the changes
measuring quality of life related to psychological health,
in the ISI between the baseline, post-treatment assess-
social relationships, and environment. It consists of 26
ment, and 1-week follow-up.
items, a shorter version than the original instrument for
The PSQI is an effective self-report questionnaire used
research studies and clinical trials. A Korean version of
to assess the quality of sleep and sleep disturbances. The
this questionnaire will be used.
PSQI is comprised of 19 items consisting of the follo-
The sleep log is a diary to be kept by the patients
wing components: subjective sleep quality, sleep latency,
themselves of their sleeping and waking times as well as
sleep duration, habitual sleep efficiency, sleep distur-
additional sleep-related information. It is a useful tool in
bances, use of sleeping medication, and daytime dys-
diagnosing insomnia and monitoring whether treatment
function. The ISI is a five-point Likert-scale self-rate
is working. Sleep logs include 16 points of information
questionnaire designed to assess the nature, severity, and
such as sleep-onset latency, waking after sleep onset,
impact of insomnia, and is widely used to measure re-
time in bed, total sleep time, number of awakenings,
sponses to treatment in research studies and clinical
sleep quality, and so on.
trials.
The K-AVLT is a Korean version of the Auditory Verbal
Learning Test normalized for Koreans and is used to
Secondary outcome evaluate verbal learning and memory abilities in terms of
Secondary outcome measures refer to scores on the BDI, neuropsychological assessment. The DS in turn measures
STAI, WHOQOL-BREF, K-AVLT, and DS, the weekly working memory and attention.
average of the components in the sleep logs during the EEGs will be recorded from 8 channels (F3, F4, Fz,
2-week period, and changes in EEG and HRV between the T3, Cz, T4, Pz and electrooculogram) with QEEG-8
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Table 1 Interventions details by Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA)
items
Item Details Intervention
1. Acupuncture rationale 1a) Style of acupuncture Traditional needle acupuncture and intradermal
acupuncture
1b) Reasoning for treatment provided based on Selected traditional acupuncture points on the 12
historical context, literature sources, and/or consensus meridian system based on the systematic review by
methods, with references where appropriate Yeung and clinical experiences
1c) Extent to which treatment was varied No variation
2. Details of needling 2a) Number of needle insertions per subject per session Five needle insertions per 1 session
(mean and range where relevant)
2b) Names (or location if no standard name) of points Neiguan (PC6), Sanyinjiao (SP6), Shenmen (HT7), Zhaohai
used (uni/bilateral) (KI6), Shenmai (BL62), all unilateral.
2c) Depth of insertion, based on a specified unit of Depth of needle insertion was at least 5 to10 mm and
measurement or on a particular tissue level intradermal acupunctured was 1 to 2 mm
2d) Response sought De-qi sensation felt by practitioner and subject
2e) Needle stimulation No stimulation and just retention without movement
Intradermal acupuncture fixed with skin tape and
subjects educated to self finger-press on them at
nighttime
2f) Needle retention time Twenty-minute retention for needles, intradermal
acupuncture patched 48 to 72 hours until next session
2 g) Needle type (diameter, length, and manufacturer Needles: 0.25 × 40 mm, stainless steel (Dong Bang
or material) Medical Co. Ltd, Korea)
Intradermal acupuncture: 0.18 × 1.3 × 1.5 mm, stainless
steel (Dong Bang Medical Co. Ltd, Korea)
3. Treatment regimen 3a) Number of treatment sessions Three sessions
3b) Frequency and duration of treatment sessions Three times per week, interval of 1 to 4 days between
sessions
4. Other components of 4a) Details of other interventions administered to the Sleep hygiene education
treatment acupuncture group
4b) Setting and context of treatment, including Same practitioner treats every subject at every session
instructions to practitioners, and information and in the same outpatient clinic
explanations to patients
5. Practitioner background 5) Description of participating acupuncturists Licensed traditional Korean medicine doctor at the
(qualification or professional affiliation, years in Kyung Hee East-West Neo Medical Center at Gangdong
acupuncture practice, other relevant experience) with more than 10 years of acupuncture treatment
experience
6. Control or comparator 6a) Rationale for the control or comparator in the Sham acupuncture points
interventions context of the research question, with sources that
justify this choice
6b) Precise description of the control or comparison Same as intervention group except 2b) and 2d)
group. If sham acupuncture or any other type of
acupuncture-like control is used, provide details as for 2b) No acupuncture points located away from
items 1 to 3 above acupuncture points at least 10 mm
2d) Without De-qi sensation

(LXE3208, LAXTHA Inc. Daejeon, Korea). The right ear- HRV will be recorded by QECG-3(LXC3203, LAXTHA
lobe (A1) will be used as a reference electrode during data Inc. Daejeon, Korea) for 5 minutes while the patient main-
recording. The electrooculograms (EOG) generated from tains a sitting posture.
eye blinks or movements shall be recorded with an elec-
trode placed approximately 1 cm below the subject’s right
outer eye can thus. Electro-physiological signals will be Safety assessment
amplified (20,000) and filtered (bandpass filter = 0.25 to The experiment will ask subjects to report adverse
50 Hz). EEG signals shall be digitized to 256 Hz. events (AEs), such as unexpected physical changes or
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side effects, in person when they visit and/or by tele- Statistical method
phone at other times during the study. The primary outcome variable for efficacy analysis is ISI,
Every adverse event reported by subjects will be de- and secondary outcomes are the PSQI, BDI, STAI,
scribed in the case report form (CRF). If the adverse WHOQOL-BREF, sleep logs, K-AVLT, DS, EEG, and
event is severe and associated with the trial, the partici- HRV. Demographics, sleep logs, ISI, PSQI, K-AVLT,
pant will be withdrawn from the study and given appro- Digit Span, STAI, TCI, EEG, and HRV will be analyzed
priate medical care. using independent sample t-tests at baseline to deter-
mine equality of the two groups. A chi-square test will
Sample size be used to assess sex differences. An efficacy analysis will
Sample size was calculated based on a ratio of 1:1 bet- be done using both per-protocol and intention-to-treat
ween the experimental and control groups. This sample analyses.
size is based on a study that investigated the effect of Independent t-tests between the two groups and a
acupuncture treatment on insomnia using ISI as a pri- repeated-measures analysis of variance (ANOVA) will be
mary outcome [30]. In that study, the mean change in used to determine and compare the effect of acupunc-
ISI between the experimental and control groups was ture. The factors are treatment (3 levels: pre-, post-
3.8 and the standard deviation was estimated as the me- acupuncture and 1-week follow-up) and groups (2 levels:
dian between the experimental (SD =4.0) and control treatment and sham) and their interaction. The signifi-
groups (SD =3.2). Based on a two-tailed alpha error of cance level was set at P <0.05 and post-hoc analyses were
5% and with a statistical power of 80%, the calculated performed where appropriate.
sample size is based on the equation:
Monitoring
 2 A qualified clinical trial expert will monitor this study.

2 þ Zβ  σ2 This trial in particular will be monitored by Gajin Han,
2
N¼ OMD, PhD, a research professor at the College of Korean
δ2
2  ð1:96 þ 0:84Þ2  3:62 Medicine, Kyung Hee University. Han is a professional
N¼ ¼ 14:07 clinical research associate, having completed a formal
3:82
training program organized by the Korea National Enter-
prise for Clinical Trials. Monitoring will commence after
Therefore, all 38 participants will be randomly the first participant completes the entire period of this
assigned with 19 subjects in each group, assuming a 20% study.
dropout rate.

Randomization Ethical considerations


An expert will randomly generate a block size (4 or 6) The Institutional Review Board (IRB), prior to subject re-
sequence using Microsoft Excel (Redmond, WA, USA). cruitment, has already approved the entire design and pro-
After that, with the allocation ratio of the experimental cedure of the clinical trial, CRF, and all measures that will
and control group within each block kept at 1:1, the be used in the study (reference number KHNMC-OH-IRB
expert will randomly generate the numbers 0 (control 2011-015, IRB at Kyung Hee University Gangdong Medical
group) or 1 (experimental group) through Microsoft Center, approved on the 13 September 2012). All subjects
Excel. This expert will not contact any of the patients must provide written informed consent prior to study
during the experiment. Once the expert generates the participation.
random numbers, the expert will seal each number in an The trial will be performed in accordance with the
opaque envelope. The expert lets the clinician know principles of good clinical practice of the Korean Food
each random number as the clinician calls a patient by and Drugs Administration and/or the Declaration of
telephone. Two other experts (neuropsychologists) - Helsinki 2008.
who measure the self-reported tests, the psychological
(cognitive) tests, the EEG and HRV - will be blinded. Discussion
Only the clinician who treats acupuncture therapy knows Standards for Reporting Interventions in Clinical Trials
what treatment the patient has been administered, but he of Acupuncture (STRICTA) were revised in 2010, yet
is prohibited from accessing any measurements for out- few studies have rigorously observed these recommenda-
comes. Double-blinding is almost impossible due to the tions. Consequently, the results of many previous studies
specifications of the acupuncture treatment. Thus, in this likely do not meet standards of objectivity and metho-
trial, only the neuropsychologist (assessor), the statistical dology. In our proposed study, all details such as acu-
expert, and patients will be blinded. points, verification tools, and use of acupuncture needles
Han et al. Trials 2014, 15:403 Page 8 of 9
http://www.trialsjournal.com/content/15/1/403

and procedures will be reported objectively following Disorders, Fifth Edition; EEG: electroencephalogram; ERPs: Event Related
STRICTA standards. Potentials; HF: high frequency; HRV: heart rate variability; IDA: intradermal
acupuncture; IRB: Institutional Review Board; ISDC-2: International
Previous trials of acupuncture treatment have focused Classification of Sleep Disorders, Second Edition; ISI: Insomnia Severity Index;
only on subjectively reported symptoms of insomnia. Con- K-AVLT: Korean-Auditory Verbal Learning Test; LF: low frequency;
sequently, they are not able to observe the mechanisms of PSQI: Pittsburgh Sleep Quality Index; STAI: State-Trait Anxiety Inventory;
STRICTA: Standards for Reporting Interventions in Clinical Trials of
acupuncture’s effect on insomnia. In the present trial, HRV Acupuncture; TCI: Temperament Character Inventory; WHOQOL-BREF: World
will be used to assess changes in the autonomic nervous Health Organization Quality of Life Abbreviated Version.
system and EEG will be used to assess changes in brain ac-
tivity in real time. These measures will objectively examine Competing interests
physiological changes due to acupuncture in real time. The authors declare that they have no competing interests.
Depression, anxiety, and decline in cognitive functions
are the main consequences of chronic insomnia as Authors’ contributions
HKH, KSY, and CSY wrote the first manuscript for this trial and calculated the
reported by many previous studies, and such symptoms sample size. HKH will monitor this trial and serve as the trial center. KSY, CSY
ultimately degrade quality of life. The effect of acupunc- are the site investigators: they initiated and will direct this study. HKH and
ture on insomnia will be verified at multi-dimensional CSY edited the first manuscript. CSY has designed all the procedures for this
protocol. All authors read and approved the final manuscript.
levels in this trial, assessing psychological and emotional
states, cognitive functions, and quality of life, allowing us
Acknowledgements
to observe how the relief of insomnia symptoms due to This study is supported by funds from Kyung Hee University (20111741).
acupuncture treatment improves patients’ quality of life.
In the trial, we will test the intradermal acupuncture Author details
1
Behavioral Research Center, Korea University, 1, 5-Ka Anam-Dong,
method particularly for enhancing the effectiveness of Sungbuk-ku, Seoul, Korea. 2Department of Hwabyung/Stress Clinic, Kyung
acupuncture for insomnia. The acupuncture is stimu- Hee University Korean Medicine Hospital at Gangdong, 149, Sangil-Dong,
lated every night by subjects applying it continuously on Gangdong-gu, Seoul, Korea.

their own, even at home. Received: 25 February 2014 Accepted: 16 October 2014
The design of the control group in studies verifying the Published: 23 October 2014
effect of acupuncture treatment is always an issue. For
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J Sleep Res. (2018) 27, 220–231 Insomnia

Self-administered acupressure for insomnia disorder: a pilot


randomized controlled trial
WING-FAI YEUNG1 , FIONA YAN-YEE HO2, KA-FAI CHUNG3,
ZHANG-JIN ZHANG , BRANDA YEE-MAN YU1, LORNA KWAI-PING SUEN1,
4

LILY YING-TUNG CHAN1, HAI-YONG CHEN4, LAI-MING HO5


and L I - X I N G L A O 4
1
School of Nursing, Hong Kong Polytechnic University, Hong Kong, China; 2Department of Psychology and Centre for Psychosocial Health, the
Education University of Hong Kong, Hong Kong, China; 3Department of Psychiatry, the University of Hong Kong, Hong Kong, China; 4School of
Chinese Medicine, the University of Hong Kong, Hong Kong, China; 5School of Public Health, The University of Hong Kong, Hong Kong,
Pokfulam, China;

Keywords SUMMARY
Acupuncture, RCT, self-acupressure, self-help, Self-administered acupressure has potential as a low-cost alternative
sleep, traditional Chinese medicine
treatment for insomnia. To evaluate the short-term effects of self-
Correspondence administered acupressure for alleviating insomnia, a pilot randomized
Dr Wing-Fai Yeung, Assistant Professor, School controlled trial was conducted. Thirty-one subjects (mean age:
of Nursing, The Hong Kong Polytechnic 53.2 years; 77.4% female) with insomnia disorder were recruited from
University; 11 Yuk Choi Road, Hung Hom,
a community. The participants were randomized to receive two lessons
Kowloon, Hong Kong, China.
Tel.: +852-2766-4151; on either self-administered acupressure or sleep hygiene education. The
fax: 852-2364-9663; subjects in the self-administered acupressure group (n = 15) were taught
e-mail: jerry-wf.yeung@polyu.edu.hk to practise self-administered acupressure daily for 4 weeks. The subjects
in the comparison group (n = 16) were advised to follow sleep hygiene
Accepted in revised form 25 July 2017; received
20 May 2017 education. The primary outcome was the Insomnia Severity Index (ISI).
Other measures included a sleep diary, Hospital Anxiety and Depression
DOI: 10.1111/jsr.12597 Scale and Short-form Six-Dimension. The subjects in the self-adminis-
tered acupressure group had a significantly lower ISI score than the
subjects in the sleep hygiene education group at week 8 (effect
size = 0.56, P = 0.03). However, this observed group difference did
not reach a statistically significant level after Bonferroni correction. With
regard to the secondary outcomes, moderate between-group effect sizes
were observed in sleep onset latency and wake after sleep onset based
on the sleep diary, although the differences were not significant. The
adherence to self-administered acupressure practice was satisfactory,
with 92.3% of the subjects who completed the lessons still practising
acupressure at week 8. In conclusion, self-administered acupressure
taught in a short training course may be a feasible approach to improve
insomnia. Further fully powered confirmatory trials are warranted.

to the Diagnostic and Statistical Manual of Mental Disorders,


INTRODUCTION
5th edition (DSM-5) (Chung et al., 2015a).
Insomnia is a common sleep disorder that is associated with Conventional pharmacological and psychological treat-
fatigue irritability, impaired daytime functioning, disturbed ments for insomnia are effective, but these therapies have
mood and even suicide (Buysse, 2013; Perlis et al., 2016; their limitations. Pharmacotherapies such as benzodi-
Taylor et al., 2007). The prevalence of insomnia accompa- azepines and non-benzodiazepine hypnotics are associated
nied by daytime consequences among the general popula- with abuse and dependence, and they have uncertain
tion worldwide is approximately 9–15% (Ohayon and efficacy with long-term use (Buysse, 2013). Cognitive
Reynolds, 2009). In Hong Kong, 10.8% of the general behavioural therapy (CBT) is supported by a large body of
population fulfilled the insomnia disorder diagnosis according evidence that it is efficacious in various delivery modalities,

220 ª 2017 European Sleep Research Society


A pilot study of self-acupressure for insomnia 221

including in individuals (Hofmann et al., 2012), in groups improving sleep, which can be a potential treatment alterna-
(Koffel et al., 2015) and as a self-help intervention (Ho et al., tive. According to previous systematic reviews on acupres-
2015). CBT for insomnia assists patients to identify and sure for improving sleep (Hmwe et al., 2016; Song et al.,
modify perpetuating factors that maintain insomnia, including 2015; Waits et al., 2016; Yeung et al., 2012), most of the
cognitive factors (e.g. dysfunctional beliefs and unrealistic included RCTs investigated practitioner-administrated acu-
expectations), behavioural factors (e.g. irregular sleep–wake pressure. The latest meta-analysis identified 13 RCTs (Waits
patterns and poor sleep habits) and physiological factors et al., 2016), and self-administered acupressure was exam-
(e.g. arousal and tension) (Morin and Benca, 2012). ined in only four RCTs involving cancer patients undergoing
Nonetheless, CBT requires extensive behavioural changes chemotherapy, menopausal women and patients with hyper-
and patients’ time for effective implementation (Morin and tension. These four studies revealed the positive effects of
Benca, 2012). self-administered acupressure on improving sleep quality,
Given the limitations of conventional treatments, patients and the pooled analysis suggested that self-administered
with insomnia commonly seek complementary health acupressure improved the Pittsburgh Sleep Quality Index
approaches (CHAs) to improve their sleep, but these CHAs score (PSQI) score in comparison with the sham and no
usually lack rigorous evidence to support their use (Leach treatment control (standardized mean difference = 1.21,
and Page, 2015; Sarris and Byrne, 2011). CHA, as defined P < 0.001) (Waits et al., 2016). A recent RCT not included
by the National Institute of Health, are medical and health- in the previous systematic reviews examined self-admini-
care systems, practices and products that derived from strated acupressure in elderly people with complaints of
outside the mainstream medicine (National Institute of sleep quality and revealed that the subjects who received
Health, 2016). A previous survey on the use of therapies self-acupressure training achieved greater improvement in
for insomnia within the previous 12 months revealed that PSQI scores in comparison with those who received sleep
17.6% of the subjects with insomnia and daytime conse- health education (effect size = 1.53) (Zeng et al., 2016).
quences had taken prescribed medication to improve their Although previous studies seemingly suggested that self-
sleep, whereas 32.1% had used at least one CHA and 3.9% administered acupressure may improve sleep quality, their
had tried acupressure (the fifth most commonly used CHA) conclusion about the efficacy of self-administered acupres-
(Yeung et al., 2014). Acupressure is a treatment modality in sure for insomnia was limited because of imprecise diagnos-
traditional Chinese medicine (TCM) and a non-invasive tic methods and lack of assessment of sleep parameters. The
variant of acupuncture, in which the practitioner stimulates previous studies were rated as having high or unclear risks of
the patient’s acupoints with the use of fingers, hands or bias because of problems in allocation concealment, blinding
elbows to facilitate the flow of qi (vital energy) along the of outcome assessor and participant compliance (Waits
meridian. However, the mechanisms for the action of et al., 2016). In addition, none of the previous studies
acupressure in improving sleep have not been investigated examined the effects of self-administered acupressure on
fully. While CBT targets dysfunctional beliefs and attitudes general adults with insomnia disorder. Given the limitation of
about sleep as well as the two-process model of sleep–wake previous RCTs and seemingly large effect sizes observed in
regulation involving circadian rhythm and sleep–wake home- the previous systematic reviews, it is warranted to examine
ostasis (Borbely, 1982; Morin and Benca, 2012), the effects the effects and feasibility of self-administered acupressure
of acupressure on sleep are proposed to involve the using a more rigorously designed RCT. Therefore, we
activation of the parasympathetic nervous system, increases proposed to conduct a pilot RCT of self-administered
in autonomous responses and reduction of psychological acupressure for adults with insomnia disorder. The specific
stress (Waits et al., 2016). A randomized controlled trial aims of this study were to: (1) test the feasibility and
(RCT) indicated that giving physical pressure to HT7 with a acceptability of training subjects to perform self-administered
wrist acupressure band improved the patients’ sleep quality acupressure through a short course; and (2) evaluate the
and increased melatonin levels (Nordio and Romanelli, short-term effects of self-acupressure for alleviating insomnia
2008). A functional magnetic resonance imaging (fMRI) in comparison with sleep hygiene education. This exploratory
study found that needling at CV12 in healthy subjects could pilot study was not powered for formal hypothesis testing.
modulate the limbic–prefrontal functional network, which is Nonetheless, the results and participants’ feedback obtained
overlapped with the functional circuits associated with emo- from this pilot study will inform the design and sample size
tional and cognitive regulation (Fang et al., 2012). Needling calculation for future fully powered trials.
at PC6 could reduce heart rate and systolic blood pressure in
healthy subjects, suggesting a sympatho-inhibitory effect
METHODS
(Abad-Alegria et al., 2001). However, more research is
needed to explore the mechanism of physical pressure on
Study design
acupoints which will allow a more in-depth comparison of
acupressure and other conventional treatments for insomnia. A pilot randomized parallel-group controlled trial was per-
Acupressure may not be the most popularly used CHA, but formed in this study. Potential subjects were assigned
previous studies suggested that it has obvious effects on randomly to either the self-administered acupressure training

ª 2017 European Sleep Research Society


222 W.-F. Yeung et al.

group or the sleep hygiene education group, with a ratio of nurse had demonstrated the teaching to the clinical psychol-
1 : 1. A computer-generated number list was used in the block ogist and principal investigator before the commencement of
randomization with a random block size of four to six, and the the study.
group allocation was enclosed in sealed, sequentially num-
bered, opaque envelopes. Research ethical approval for all the
Interventions
study procedures was obtained from the local institutional
review board, and the study was registered in ClinicalTrials.- Both groups were provided with two 120-min training courses
gov (ClinicalTrials.gov identifier: NCT03053648). This trial (240 min in total) on a weekly basis. The group size was
followed the Consolidated Standards of Reporting Trials small, at four to six participants, to enhance interaction and
(CONSORT) (Moher et al., 2012) and Standards for Reporting quality of teaching. The subjects in both groups received the
Interventions in Clinical Trials of Acupuncture (STRICTA) same assessment procedures and the same number of
(Macpherson et al., 2010) recommendations for designing contact hours with the research personnel. The subjects were
and reporting. Recommendations on future trials would be not paid for participation.
based on the subjects’ feedback (acceptability), feasibility of
the short training course (subjects’ fidelity and adherence) and
Self-administered acupressure training course
effects of self-administered acupressure for insomnia (effect
sizes in the treatment outcome). The protocol of self-administered acupressure was devel-
oped on the basis of previous systematic reviews (Hmwe
et al., 2016; Song et al., 2015; Waits et al., 2016; Yeung
Subjects
et al., 2012) and the experience in acupuncture of the senior
Thirty-one participants were recruited from the community authors (LL and ZJZ). In the first lesson, introduction to
through posters disseminated around the university and acupressure, therapeutic actions and functions of each
through magazine advertisements from December 2016 to acupoint according to TCM theory were explained. A hand-
February 2017. Eligible participants were identified on the out with a step-by-step guide and pictures providing infor-
basis of the criteria: (1) aged 18–65 years; (2) Chinese mation about administering self-administered acupressure
Hong Kong residents with proficiency in Cantonese or was provided to each participant. The details of the acupoints
Putonghua; (3) fulfilling the diagnostic criteria of DSM-5 and self-administered acupressure procedures are listed in
insomnia disorder (difficulty in falling asleep and staying Table 1. Afterwards, the participants received training in
asleep or early morning awakening for at least 3 months, locating acupoints and performing acupressure techniques,
along with significant daytime consequences) using the Brief followed by a group practise session. The instructor
Insomnia Questionnaire (sensitivity: 0.55; specificity: 0.87; inspected their practise and provided feedback or correction
area under the receiver operating characteristic curve: 0.76; when necessary. Finally, the instructor presented a brief
test–retest reliability: Pearson’s r = 0.4–0.7) (Chung et al., summary of the course and answered questions regarding
2014); (4) a clinical insomnia level with a score of at least 10 the mastery of self-acupressure techniques. The participants
points in the Insomnia Severity Index (ISI) (Morin, 2011); were told to perform self-administered acupressure (around
and (5) willingness to give consent and comply with the 12–20 min) every night for 30 min prior to sleep for 4 weeks.
protocol. The exclusion criteria included the following: The duration was based on previous systematic reviews that
pregnancy; score of ≤ 23 (indicative of cognitive impairment) beneficial effects were observed after 4 weeks of treatment
in the Mini Mental State Examination (MMSE); significant (Waits et al., 2016; Yeung et al., 2012). In the second lesson,
suicidal risk determined with the rating of ≥ 3 points in the the instructor answered the subjects’ specific queries during
Hamilton Depression Rating Scale (suicide item); sleep home practise, reviewed course contents and inspected the
disorders requiring treatment (e.g. sleep apnea); consump- participants’ self-acupressure techniques. The instructor
tion of over-the-counter medication, herbal remedies or checked the participants’ mastery of self-acupressure tech-
psychotrophic drugs for insomnia within 2 weeks; and niques using a competency checklist before the end of each
receipt of acupuncture or practitioner-delivered acupressure lesson.
in the previous 6 months.
Sleep hygiene education
Therapists’ background
The subjects in the comparison group were given sleep
Self-acupressure training was provided by a registered hygiene education (Harsora and Kessmann, 2009; Morin and
Chinese medicine practitioner with at least 5 years of clinical Espie, 2003). At the beginning of the first lesson, a sharing
experience in providing acupuncture and acupressure. The session was conducted to allow the participants to share and
instructor for sleep hygiene education was a registered nurse discuss their sleep problems. A training hand-out covering
who had been engaged in sleep research and trained by a activity schedules and sleep hygiene instructions was deliv-
clinical psychologist. The clinical psychologist’s research ered to each subject. These instructions included a dark and
postgraduate studies were specialized in sleep research. The quiet sleep environment, separate from other activities; and

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A pilot study of self-acupressure for insomnia 223

Table 1 Selected self-acupressure acupoints for relieving insomnia

Acupoint Location (Zhang et al., 2014) Acupressure technique Frequency and duration

Baihui On the vertex of the head at the sagittal Using four finger pads, gently tap the 60 min 1
for 1 min
(GV20, 百會) midline of the scalp at the mid-point of area of this acupoint on the scalp
the line connection the apexes of both
ears
Fengch On the nape, in a depression between Using two thumbs, press on the points 60 min 1 for 1 min (both
(GB20, 風池) the upper portion of the bilaterally while the other four fingers sides at the same time)
sternocleidomastoid muscle and the should hold the back of the head
trapezius naturally
Neguan On the medial aspect of the forearm Using thumb pad, firmly massage the 60 min 1 for 1 min
(PC6, 內關) between the palmaris longus and flexor surrounding area of this acupoint (bilateral, 2 min in total)
carpi medial tendons, 2 cun proximal to unilaterally on the medial side of the
the palmar wrist crease wrist
Shenmen On the posteromedial aspect of the wrist Using thumb pad, firmly massage the 60 min 1 for 1 min
(HT7, 神門) radial to the flexor carpi ulnaris tendon surrounding area of this acupoint (bilateral, 2 min in total)
at the palmar wrist crease unilaterally on the ulnar side of the wrist
Zhongwan On the upper abdomen and on the Using finger pads, gently massage the 100 min 1
for 2 min
(CV12, 中脘) anterior midline, 4 cun above the centre upper abdomen area in a clockwise
of the umbilicus circle, 4 cun above the umbilicus
Yongquan On the sole, in depression with the foot in Using thumb pad, firmly massage the 40 min 1 for at least 2 min
(KD1,涌泉) plantar flexion, at the junction of the area bilaterally on each sole, in (bilateral, 4 min in total)
anterior 1/3 and posterior 2/3 of line depression with foot in plantar flexion
connecting base of the 2nd and 3rd toes
with the heel

encouraging the increase of daytime activity, regular meals insomnia, to reinforce their learning. Finally, the instructor
and bedtime routine and avoidance of nap-taking and looking reviewed the course contents and checked the participants’
at the clock when waking at night. The rationale for each understanding of the sleep hygiene instructions. The training
instruction and a discussion about possible solutions were session would be adjourned when all the subjects had
included. The subjects’ understanding of their sleep habits expressed understanding of the instructions.
was enhanced by completing the Sleep Hygiene Practice Sleep hygiene education has been used commonly as a
Scale (SHPS) (Lin et al., 2009) and the Caffeine Knowledge comparison group in RCTs of self-help and psychological
Quiz (Anderson et al., 2009). The SHPS covered four interventions for insomnia. Sleep hygiene education will
dimensions—sleep schedule and timing (e.g. regular bedtime provide subjects with the same amount of contact hours with
and avoiding emotional activities before bed time), arousal- the health-care professional (instructor) to control the non-
related behaviours (e.g. timing of exercise and nap), drinking specific effect of practitioner–patient interaction in the self-
and eating habits (e.g. regular meal, problems of smoking, administered acupressure group.
caffeine and alcohol) and sleep environment (e.g. bedroom
setting and bed partner). The items in SHPS and the Caffeine
Telephone reminder
Knowledge Quiz would be discussed with the subjects and
explained by the course instructor. Subjects would be told to During the first 4 weeks, the instructors made a telephone
follow the 10 items of sleep hygiene, which included (1) avoid follow-up for both groups twice a week to remind the
napping; (2) no smoking within 2 h before bedtime; (3) avoid participants about their practise at home and to answer
eating heavily near bedtime; (4) avoid performing vigorous subjects’ queries. The subjects in the self-administered
physical activities within 2 h before sleep; (5) avoid being acupressure group were told to perform acupressure daily
hungry or thirsty; (6) avoid thinking about the day’s events for 4 consecutive weeks (weeks 1–4) and complete an
and worrying in bed; (7) avoid engaging with highly demand- acupressure log to record their home practise. Continuous
ing activities near to bedtime; (8) no activities in bed other practise was encouraged, but it was not made mandatory
than sleep; (9) prepare the bedroom to be comfortable in during weeks 5–8. The subjects in the sleep hygiene
terms of temperature, light and noise; and (10) sleep and education group were asked to check whether they had
wake at a regular time (Yazdi et al., 2016). During the second followed the sleep hygiene education and recorded entries in
lesson, the subjects’ questions about the home practice of the sleep hygiene log. The subjects in the sleep hygiene
sleep hygiene instructions were answered and discussed in education group received the same self-administered acu-
class. Thereafter, the subjects completed the SHPS again, pressure training after the study period as compensation. The
along with a ‘true or false’ test regarding some facts about course schedule is presented in Fig. 1.

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224 W.-F. Yeung et al.

Baseline Week 4 Week 8


assessment assessment assessment

Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8

Mandatory treatment period Non-mandatory treatment period


Phone reminders were made twice per Subjects were encouraged to, but not
week to remind subjects of practising mandatory, continue practising. No
acupressure or follow sleep hygiene phone reminders were made.
instrcutions

1st lesson Subjects in the SHE group received self-


administered acupressure training after
2nd lesson completion of all follow-up assessments

Figure 1. Schedule of self-administered acupressure training course and sleep hygiene education (SHE) course.

regarding the effects of intervention for their complaints


Fidelity check of self-acupressure
(Vincent, 1990). The adapted Chinese version of the sleep
To ensure the subjects’ performance of self-administered diary has been used in previous RCTs (Chung et al.,
acupressure, the course instructor evaluated every partici- 2015b; Ho et al., 2014). The calculation of SE was based
pant’s mastery of self-acupressure with a competency on the TST and time in bed (TIB) derived from
checklist in each lesson. The checklist included items on the recorded time of lights out and getting out of bed
the accuracy of locating acupoints, acupressure techniques sleep diary with the following equation: SE = TST/
and strength and duration of acupressure for each acupoint. TIB 9 100%.
Any identified discrepancy in treatment fidelity was corrected, The primary outcome ISI and the sleep diary were
and extra practise time and specific instructions were given evaluated after completion of training (week 2), the end-of-
by the instructor as necessary. treatment period (week 4) and the 4-week post-treatment
follow-up (week 8). Other secondary outcome assessments
were assessed at baseline and weeks 4 and 8. Adverse
Outcome measures
events were recorded during each visit, and the subjects’
The primary outcome was the ISI (Bastien et al., 2001), a acceptability concerning self-administered acupressure was
validated measure of perceived severity of insomnia and assessed using a 10-point single item scale (ranging from 1
daytime impairments (scores ranged from 0 to 28, Cron- to 10) after completion of the training course. Specific
bach’s alpha = 0.74). The Chinese version of ISI was assessments regarding the course, such as acceptability,
validated with good internal consistency (Cronbach’s alpha acupressure and sleep hygiene log and record of adverse
of = 0.83) and test–retest reliability (Pearson’s r = 0.79) events were conducted and analysed by the course instruc-
(Chung et al., 2011). The secondary outcomes included a tors. The research assistant who performed the outcome
7-day sleep diary, which is a daily record capturing the bed assessment and data analysis was blinded to the treatment
and wake information for the estimation of sleep onset allocation.
latency (SOL), wake after sleep onset (WASO), total sleep
time (TST) and sleep efficiency (SE) (Carney et al., 2012);
Statistical analysis
the Hospital Anxiety and Depression Scale (HADS), which
is a self-rated questionnaire for measuring the severity of We used SPSS version 23.0 (IBM Corporation, Armonk, NY,
depressive and anxiety symptoms (Zigmond and Snaith, USA) for all the statistical analyses. The primary analysis was
1983); and the Chinese version of HADS showed a conducted using a linear mixed-effects model to examine the
Cronbach’s alpha of 0.86 (Leung et al., 1999). The Short- groups (self-administered acupressure versus sleep hygiene
form Six-Dimension (SF-6D) is a multi-level evaluation of education) 9 time (baseline to week 8) interactions on the
quality of life (Brazier et al., 2002); the Chinese version primary outcome ISI score and other secondary outcomes,
SF-6D was evaluated in a Chinese population, showing an including sleep parameters and other questionnaires. Miss-
intraclass correlation of 0.79 and with a mean absolute ing data were dealt with using the mixed-effects model,
error of 0.054 in fitting into the econometric model (Lam assuming missing at random. Both completers and intention-
et al., 2008). The Credibility of Treatment Rating Scale to-treat analyses were conducted. Completers analysis
(CTRS, Cronbach’s alpha = 0.73; test–retest reliability, included only the subjects who had completed the training
Pearson’s r = 0.82) assesses subjects’ expectations courses and complied with the intervention protocol, defined

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A pilot study of self-acupressure for insomnia 225

as having self-administered acupressure practice at home or determine the appropriate sample size for this study by
following the sleep hygiene instruction for at least 4 days per G*Power version 3.1.9.2.
week, as recorded by the acupressure or sleep hygiene log
during the treatment period (up to week 4). Between-group
RESULTS
effect sizes were computed by dividing the difference
between group means by the pooled standard deviation.
Subject characteristics
Within-group effect sizes were computed by dividing the
mean difference between baseline and post-treatment A total of 31 participants were finally recruited (Fig. 2). The
assessment by the pooled standard deviation (SD). We used subjects’ characteristics and baseline assessment are pre-
a positive sign to denote that the treatment group was sented in Table 1. The recruited participants had an average
superior to the comparison group for between-group effect age of 53.2 years (SD = 9.0). They were mainly female
sizes and post-treatment assessment was superior to the (77.4%), and most of them had tried alternative treatments
baseline assessment for within-group effect sizes. We used previously for insomnia (87.1%). Approximately 12.9% of the
Bonferroni correction to adjust multiple time-points in com- subjects had a history of mental illness, and 41.9% were on
parison with conservative thresholds of P < 0.017 and regular medications for their medical illnesses. At baseline,
P < 0.025 in sleep outcomes (three time-points) and other the mean scores of ISI was 17.0 (SD = 3.8), indicating a
secondary outcome measures (two time-points), respec- moderate insomnia severity. Fifteen participants were allo-
tively. A post-hoc power analysis was conducted to cated to the self-acupressure group and 16 participants to the

Assessed for eligibility


(n = 63) Excluded (n = 23)
Fail to contact (n = 5)
Did not fulfil DSM-5 insomnia disorder (n = 4)
Having treatment for other sleep disorder (n = 1)
Taking over-the-counter medicine (n = 1)
Incompatible working schedule (n = 3)
Study recruitment termination (n = 9)

Eligible for face-to-face


interview (n = 40)

Excluded (n = 9)
Refuse to participate (n = 3)
Withdrew consent (n = 3)
Incompatible working schedule (n = 2)
Study recruitment termination (n = 1)
Randomization (n = 31)

Self-administered acupressure Sleep hygiene education (n = 16)


(n = 15)

Completed 1st training lesson


Completed 1st training lesson (n = 16)
(n = 15)

Completed 2nd training lesson


Completed 2nd training lesson (n = 16)
(n = 13)
Incompatible schedule (n = 1); withdrew consent due to
adverse event (n = 1)

Completed week 4 assessment


Completed week 4 assessment (n = 15)
(n = 13)

Completed week 8 assessment


Completed week 8 assessment (n = 14)
(n = 13)

Analysed (n = 16)
Analysed (n = 15)

Figure 2. Consolidated Standards of Reporting Trials (CONSORT) study flow diagram.

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226 W.-F. Yeung et al.

Table 2 Sociodemographic, clinical and baseline characteristics of the sample

All participants Self-acupressure Sleep hygiene P-value


Variablea (n = 31) (n = 15) (n = 16) t-test/chi-square

Age, years 53.2  9.0 50.4  11.0 55.8  6.0 0.10


Female gender (%)c 24 (77.4) 12 (80) 12 (75) 1.00
Educational level, years 13.0  4.7 14.5  4.3 11.5  4.8 0.08
Marital status (%)c
Never married 13 (41.9) 8 (53.3) 5 (31.3) 0.20
Married/cohabiting 15 (48.4) 7 (46.7) 8 (50.0)
Divorced/widowed 3 (9.7) 0 (0) 3 (18.7)
Employment status (%)
Employed 15 (48.4) 8 (53.3) 7 (43.7) 0.59
Unemployed/retired/housework 16 (51.6) 7 (46.7) 9 (56.3)
Income, HK$ (%)c
No income 8 (26.7) 4 (26.7) 4 (25.0) 0.83
Below $10 000 3 (10.0) 1 (6.6) 2 (12.5)
$10 000–50 000 13 (43.3) 6 (40.0) 7 (43.8)
Above $50 000 6 (20.0) 4 (26.7) 2 (12.5)
BMI 22.4  3.4 23.1  3.6 21.9  3.3 0.35
Chronic medical illnesses (%)b 13 (41.9) 5 (33.3) 8 (50.0) 0.35
History of mental illness (%)c 4 (12.9) 2 (13.3) 2 (12.5) 1.00
Insomnia duration, years 7.6  10.1 6.9  9.9 8.3  10.6 0.71
History of hypnotics use (%)c 8 (25.8) 2 (13.3) 6 (37.5) 0.22
Alternatives treatment for insomnia (%)d 27 (87.1) 12 (80.0) 15 (93.8) 0.25
ISI 17.0  3.8 17.1  4.4 16.8  3.4 0.82
Sleep diary
Sleep onset latency 41.5  27.5 38.8  16.5 44.5  35.3 0.60
Wake after sleep onset 52.0  39.1 41.0  27.5 62.3  46.0 0.13
Total sleep time 331.9  65.2 340.3  49.7 324.1  77.8 0.49
Sleep efficiency 69.7  14.3 73.5  11.6 66.2  16.1 0.16
Sleep quality 2.4  0.5 2.4  0.5 2.4  0.6 0.80
HADS
Anxiety 10.0  3.8 10.3  3.5 9.8  4.3 0.75
Depression 7.5  3.7 7.1  3.4 7.9  4.0 0.58
SF-6D utility score 0.639  0.115 0.641  0.107 0.637  0.125 0.92
CTRS
Confidence in effectiveness 4.19  1.08 4.40  1.06 4.00  1.10 0.31
Confidence in recommending to others 4.19  1.20 4.40  1.18 4.00  1.21 0.36
Perceived logic 4.45  0.96 4.60  1.12 4.31  0.79 0.41
Likelihood of relieving other complaints 4.16  1.00 4.40  0.91 3.94  1.06 0.21

BMI, body mass index; ISI, Insomnia Severity Index; HADS, Hospital Anxiety and Depression Scale; SF-6D, Short-Form Six-Dimension.
a
Data are presented as mean  standard deviation or number (%).
b
Participants were on regular medications for their medical illnesses.
c
Fisher’s exact test was performed.
d
Experience of alternative treatment other than hypnotics included herbal medicine, acupuncture/acupressure, exercise, massage, alcohol,
aromatherapy, relaxation therapy and Tai Chi.

sleep hygiene education group. No significant between-group the self-acupressure techniques and passed the fidelity
differences were observed in their demographic factors and check after the course. During the 28-day treatment period,
baseline assessments (all P > 0.05, Table 2). all 13 subjects who had completed the self-administered
acupressure training course practised acupressure for
25.2 days (range: 22–28 days) and 14.8 min per day (range:
Treatment acceptability, fidelity and compliance
5–50 min) on average. At week 8, 12 subjects (92.3% of
The overall mean rating for acceptability of the self- those who had completed the course) still practised acu-
administered acupressure training course was 9.0 (SD = 1.0, pressure, with an average of 6.1 days per week and 12.9 min
range: 7–10), indicating a high acceptability among the per day (range: 5–38 min). For the subjects in the sleep
subjects to learn and perform self-administered acupressure. hygiene education group, all subjects had attended all
The compliance was good; 86.7% of the subjects attended all lessons and 14 had returned their sleep hygiene log; 85.7%
the self-administered acupressure training lessons. In the had followed at least eight sleep hygiene instruction items
self-administered acupressure group, all the subjects learned during the 28-day treatment period and at week 8.

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A pilot study of self-acupressure for insomnia 227

HADS depression scores across all assessment time-points


Primary outcome
(Table 4).
The differences in the ISI scores of the self-administered Although the item of ‘confidence in recommending to
acupressure group and sleep hygiene education group others’ in the CTRS showed a significant between-group
across study time-points were compared using mixed-effects difference (P = 0.046), the difference was not signifi-
model analysis (Table 3). No significant group difference was cant after Bonferroni correction (Table 5). A completers’
observed in the ISI scores at weeks 2 and 4. The subjects in analysis showed consistent findings on the secondary
the self-administered acupressure group had significantly outcomes.
lower ISI scores than those who received sleep hygiene
education at week 8 (effect size = 0.56, P = 0.03). However,
Adverse events
this observed group difference did not reach a statistically
significant level after Bonferroni correction for assessing In the self-administered acupressure group, one subject
multiple endpoints. The result was not altered in the exerted acupressure too strongly with his fingernail, leading
completers analysis. to mild bleeding; two subjects experienced a stomach ache
after performing acupressure on the abdomen. The adverse
events experienced by these subjects were mild, and no
Secondary outcomes
treatment was needed. However, one subject complained of
The SOL, WASO, TST and SE derived from the sleep diary worsened insomnia symptoms and dropped out during the
did not differ significantly between the two groups at any of second week. In the sleep hygiene education group, one
the time-points (Table 3). In addition, no between-group subject complained of low back pain and withdrew from the
difference was found in SF-6D, HADS anxiety scores and study during week 4.

Table 3 Insomnia Severity Index (ISI) and sleep parameters derived from the 7-day sleep diary across study time-points

Self-administered acupressure (n = 15) Sleep hygiene education (n = 16)

Change from Change from


Estimated baseline Within-group Estimated baseline Within-group Between-group P-
mean (SE)a mean (SE)a effect sizeb mean (SE)a mean (SE)a effect sizeb effect sizec valued

ISI
Baseline 17.13 (1.32) 16.81 (1.28)
Week 2 12.79 (1.37) 4.39 (1.19) 0.83 15.02 (1.31) 1.82 (1.13) 0.35 0.42 0.08
Week 4 12.88 (1.37) 4.31 (1.19) 0.82 14.63 (1.30) 2.20 (1.11) 0.42 0.33 0.17
Week 8 10.88 (1.37) 6.31 (1.19) 1.20 13.87 (1.32) 2.97 (1.13) 0.57 0.56 0.03
SOL, min
Baseline 38.79 (7.26) 44.12 (7.03)
Week 2 23.68 (7.54) 14.08 (6.38) 0.53 34.82 (7.28) 9.78 (6.15) 0.32 0.38 0.49
Week 4 26.10 (7.51) 11.80 (6.38) 0.44 44.51 (7.26) 0.02 (6.15) 0.01 0.63 0.10
Week 8 17.76 (7.93) 20.51 (6.61) 0.71 35.14 (7.26) 9.40 (6.15) 0.31 0.58 0.15
WASO, min
Baseline 41.00 (10.47) 62.32 (10.14)
Week 2 27.70 (10.88) 13.13 (7.80) 0.32 55.80 (10.50) 7.69 (7.52) 0.16 0.67 0.575
Week 4 24.53 (10.76) 16.36 (7.80) 0.40 59.57 (10.40) 3.52 (7.52) 0.07 0.84 0.167
Week 8 22.85 (11.27) 18.16 (8.59) 0.43 38.64 (10.43) 24.58 (7.52) 0.58 0.37 0.620
TST, min
Baseline 340.28 (17.53) 324.06 (16.98)
Week 2 350.45 (17.90) 9.63 (12.52) 0.15 332.83 (17.31) 10.31 (12.06) 0.13 0.25 0.92
Week 4 350.23 (17.97) 9.29 (12.52) 0.14 317.90 (17.37) 4.29 (12.06) 0.09 0.46 0.31
Week 8 363.62 (18.65) 20.15 (13.20) 0.33 341.25 (17.38) 19.13 (12.06) 0.25 0.32 0.72
Sleep efficiency, %
Baseline 73.46 (4.08) 66.17 (3.95)
Week 2 78.44 (4.17) 4.83 (2.88) 0.31 71.47 (4.03) 5.52 (2.77) 0.33 0.43 0.92
Week 4 76.90 (4.17) 3.30 (2.88) 0.22 68.30 (4.03) 2.35 (2.77) 0.13 0.53 0.69
Week 8 81.40 (4.30) 6.62 (2.98) 0.49 72.88 (4.03) 6.93 (2.77) 0.42 0.52 0.72

SOL, sleep onset latency; WASO, wake after sleep onset; TST, total sleep time.
a
Estimated mean and standard error (SE) from linear mixed-effects model.
b
Effect size calculation was based on the difference of estimated mean and standard deviation comparing each time-point and baseline.
c
Effect size calculation was based on the between-group difference in total scores divided by pooled standard deviation.
d
P-value for group 9 time interaction of mean score using linear mixed-effects models.

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228 W.-F. Yeung et al.

Table 4 Hospital Anxiety and Depression Scale (HADS), Short-Form Six-Dimension (SF-6D) and Credibility of Treatment Rating Scale
(CTRS) scores across study time-points

Self- administered acupressure


(n = 15) Sleep hygiene education (n = 16)

Estimated Within-group Estimated Within-group Between-group


mean (SE)a effect sizeb mean (SE)a effect sizeb effect sizec P-valued

HADS–anxiety
Baseline 10.27 (0.88) 9.81 (0.86)
Week 4 8.26 (0.96) 0.56 8.79 (0.90) 0.29 0.14 0.43
Week 8 8.71 (1.06) 0.41 8.30 (0.90) 0.43 0.11 0.97
HADS–depression
Baseline 7.13 (0.86) 7.88 (0.83)
Week 4 6.35 (0.91) 0.23 7.34 (0.86) 0.16 0.28 0.81
Week 8 6.44 (1.02) 0.19 6.79 (0.88) 0.32 0.09 0.78
SF-6D, 0-1
Baseline 0.641 (0.030) 0.637 (0.029)
Week 4 0.672 (0.032) 0.26 0.635 (0.030) 0.02 0.30 0.43
Week 8 0.649 (0.036) 0.06 0.658 (0.031) 0.17 0.07 0.78
a
Estimated mean and standard error (SE) from linear mixed-effects model.
b
Effect size calculation was based on the difference of estimated mean and standard deviation comparing each time-point and baseline.
c
Effect size calculation was based on the between-group difference in total scores divided by pooled standard deviation.
d
P-value for group 9 time interaction of mean score using linear mixed-effects models.

Post-hoc power analysis Table 5 Credibility of Treatment Rating Scale (CTRS) across
study time-points
The post-hoc power analysis revealed that the powers of the
present sample size in determining the difference in ISI at Self- administered Sleep hygiene
week 4 (effect size = 0.33) and week 8 (effect size = 0.56) acupressure (n = 15) education (n = 16)
were 15 and 33%, respectively. The effect size estimated in Estimated Estimated P-
mean (SE)a mean (SE)a valueb
this study suggested that a sample size of 56 in each group
was needed to detect between-group differences in ISI CTRS–confidence in effectiveness
scores at week 8 with a power level of 80%. Baseline 4.40 (0.27) 4.00 (0.26)
Week 4 4.12 (0.28) 3.38 (0.27) 0.28
Week 8 4.06 (0.32) 3.45 (0.27) 0.58
DISCUSSION CTRS–confidence in recommending to others
Baseline 4.40 (0.28) 4.00 (0.27)
The present study is the first RCT, to our knowledge, to Week 4 4.63 (0.30) 3.52 (0.28) 0.046
examine the effects of self-administered acupressure on Week 8 4.48 (0.35) 3.60 (0.29) 0.27
adults with insomnia disorder. This pilot trial was aimed at CTRS–perceived logic
Baseline 4.60 (0.25) 4.31 (0.24)
examining the feasibility of training participants to perform Week 4 4.61 (0.27) 4.12 (0.25) 0.54
self-administered acupressure through a two-session training Week 8 4.40 (0.31) 3.69 (0.25) 0.28
course and at generating estimates of effect sizes for future CTRS–likelihood of relieving other complaints
fully powered studies. The effects of self-administered Baseline 4.40 (0.28) 3.94 (0.27)
acupressure were most pronounced in the ISI score at week Week 4 4.09 (0.30) 3.36 (0.28) 0.55
Week 8 3.93 (0.36) 3.43 (0.28) 0.95
8, although it did not reach a significant level after correction
for multiple comparisons. Moderate effect sizes were a
Estimated mean and standard error (SE) from linear mixed-effects
observed in the sleep diary-derived SOL at weeks 4 and 8, model.
and a large effect size was observed in WASO at week 4.
b
P-value for group 9 time interaction using linear mixed-effects
models.
These differences were not significant due to the small
sample size of this pilot trial.
The adherence to at-home self-administered acupressure participants to perform self-administered acupressure at
practice was satisfactory, with a completion rate of 86.7% for home. Future studies should include a fidelity check at the
the training course. After the training course, all participants end of the follow-up period to assess subjects’ learning of the
were trained to perform self-administered acupressure suc- acupressure technique.
cessfully and passed the fidelity check. This study showed Our results showed that unlike sleep hygiene education,
that our training course is feasible for the training of self-administered acupressure produced a moderate effect

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A pilot study of self-acupressure for insomnia 229

size in the improvement of ISI score. Previous studies used a research focus was in sleep medicine. In order to ensure
sham or waiting list as a control and studied a somewhat quality and comprehensive coverage of the sleep hygiene
specific population, such as lung cancer patients undergoing course instruction, the instructor can be trained by a clinician
chemotherapy (Tang et al., 2014), menopausal women or psychologist in formal sleep medicine training. Finally,
(Abedian et al., 2015) and patients with hypertension (Zheng despite the fact that the self-administered acupressure
et al., 2014). Therefore, the effect sizes of the pilot trial technique is not complicated, and all subjects could learn
cannot be compared directly with those of existing studies. the acupressure technique after the training course and after
Similar to our comparison group design, Zeng et al. adopted passing the fidelity check by the instructor in our pilot study,
sleep health instructions to examine the effects of self- we cannot rule out the possibility that a few participants did not
administered acupressure on elderly people with poor sleep follow the instructions fully when they practised the technique
(Zeng et al., 2016). In the study, a significantly large effect at home. Nevertheless, our results reflected real-world prac-
size (1.54) on improving the sleep questionnaire score was tice and presented important information about the imple-
found (Zeng et al., 2016), in contrast to the moderate effect mentation of the training course in the community.
size (0.56) found in this study. This difference is due probably In summary, our short training course showed high
to the longer treatment duration (12 months), higher treat- acceptability and subject adherence. In addition, several
ment intensity (30 min, twice per day) and additional home medium-to-large effect sizes favoured the intervention group,
visits in their study in comparison with the current study. suggesting that self-administered acupressure taught
Further studies can be carried out to investigate the optimal through a short training course may be a feasible approach
treatment duration and intensity of performing self-adminis- to improve insomnia. Given the low cost and convenient
tered acupressure. nature of self-administered acupressure, further fully pow-
In the present study, the subjects in the sleep hygiene ered confirmatory trials are warranted.
education group appeared to have a longer WASO, lower SE
and lower confidence regarding the intervention, although the
ACKNOWLEDGEMENTS
differences were not statistically insignificant. A previous
secondary analysis found that baseline insomnia severity This study required no financial support.
was a predictive factor for treatment response in acupuncture
(Yeung et al., 2017). These factors can be controlled as
AUTHOR CONTRIBUTIONS
covariates to increase the power in future studies. In addition,
subjects’ confidence regarding the intervention may be WFY conceived and designed the trial. LXL, ZZJ and HYC
associated with their motivation and readiness to change. provided expert opinion to the self-acupressure protocol.
Interim assessment of the confidence and acceptability of the KPS and YYH reviewed the sleep hygiene education
intervention can be examined as a moderator or mediator to instructions and provided training of personnel. WFY and
explain its effectiveness. YTC performed the self-acupressure and sleep hygiene
education training courses, respectively. YMY conducted the
assessments. WFY and YMY analysed the data and drafted
Limitations
the manuscript. KFC, ZZJ, KPS, YYH and HYC revised the
Our study had several limitations, apart from the small sample manuscript. All authors approved the final version accepted
size. First, no objective sleep measures, such as for publication.
polysomnography or actigraphy, were used as outcome
measures due to limited resources. Nevertheless, we adopted
CONFLICT OF INTEREST
essential subjective sleep assessment (Buysse et al., 2006),
including a validated sleep questionnaire and 7-day prospec- All authors declare that there are no conflicts of interest.
tively recorded sleep diary, which had not been included in the
previous studies (Waits et al., 2016). Future studies should
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