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Patient Education and Counseling 98 (2015) 182–190

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Patient Education and Counseling


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Intervention

Effects of guided deep breathing on breathlessness and the breathing


pattern in chronic obstructive pulmonary disease: A double-blind
randomized control study
Christine R. Borge a,b,1,*, Anne Marit Mengshoel a, Ernst Omenaas c, Torbjørn Moum d,
Inger Ekman e, Martha P. Lein b, Ulrich Mack b, Astrid K. Wahl a
a
Department of Health Sciences, University of Oslo, Norway
b
Department of Medicine, Lovisenberg Diaconal Hospital, Oslo, Norway
c
Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway
d
Department of Behavioral Sciences in Medicine, University of Oslo, Norway
e
Institute of Health and Care Sciences, the Sahlgrenska Academy, University of Gothenburg Sweden and Centre for Person-centered care,
University of Gothenburg, Sweden

A R T I C L E I N F O A B S T R A C T

Article history: Objective: To investigate whether guided deep breathing using a device improves breathlessness, quality
Received 26 April 2014 of life, and breathing pattern in moderate and severe stage of chronic obstructive pulmonary disease
Received in revised form 15 August 2014 (COPD).
Accepted 19 October 2014
Methods: In total, 150 patients participated in a double-blind randomized controlled trial in a four-week
intervention and a four-month follow-up. Participants were randomized into a guided deep breathing
Keywords: group (GDBG), music listening group (MLG), or sitting still group (SSG). The patients’ symptom score
COPD
using the St George’s Respiratory Questionnaire (SGRQ), and a Global Rating Change scale (GRC) was
Breathlessness
Quality of life
applied to measure breathlessness as primary outcome. The activity score and impact score of SRGQ, and
Randomized control trial breathing pattern were secondary outcomes.
Self-management Results: Positive effects of the GDBG were detected in GRC scale in breathlessness at four weeks
(p = 0.03) with remaining effect compared to MLG (p = 0.04), but not to SSG at four months follow-up.
GDBG showed positive effect for respiratory rate (p < 0.001) at four weeks follow-up. A positive
significant change (p < 0.05–0.01) was found in all groups of SGRQ symptom score.
Conclusion: GDBG had a beneficial effect on respiratory pattern and breathlessness. MLG and SSG also
yielded significant improvements.
Practice implications: Guided deep breathing may be used as a self-management procedure.
ß 2014 Elsevier Ireland Ltd. All rights reserved.

1. Introduction QOL are important aims for patient care and treatment approaches
[3]. The use of pharmacological treatments alone is not effective;
Chronic obstructive pulmonary disease (COPD) is demanding for thus, additional nonpharmacological approaches such as breath
the individual patient and the symptom breathlessness and impaired retraining exercises have been suggested [4].
quality of life (QOL) [1,2] increase during the more severe stages of COPD is caused by a complex array of physical changes such as
the disease [3]. Breathlessness is often the reason why patients with chronic obstruction of the airways and destroyed alveoli. This may
COPD seek medical help. Thus, relieving symptoms and improving lead to an overload or fatigue of respiratory muscles, disturbances of
gas exchange between the lung and blood and air trapping
[4]. Hence, people with COPD may develop an ineffective breathing
* Corresponding author at: Institute of Health and Society, Department of Health pattern in form of an insufficient ventilation, resulting in an
Sciences, PB 1089 Blindern, 0317 Oslo, Norway. Tel.: +47 22845372; increased respiratory rate (RR), decreased vital capacity, and
fax: +47 22845091. decreased time on inspiration (TIN), and expiration (TEX), which
E-mail addresses: c.r.borge@medisin.uio.no, christineraaheim.borge@lds.no are also associated with symptoms of breathlessness/dyspnea [5,6].
(C.R. Borge).
1 Diaphragmatic breathing, deep breathing, yoga breathing, and
Lovisenberg Diaconal Hospital, Medical Department, 0440 Oslo, Norway.
Tel.: +47 23225000. pursed-lip breathing are breathing exercises that can affect the

http://dx.doi.org/10.1016/j.pec.2014.10.017
0738-3991/ß 2014 Elsevier Ireland Ltd. All rights reserved.
C.R. Borge et al. / Patient Education and Counseling 98 (2015) 182–190 183

ability [7] to improve an ineffective breathing pattern, to breathe Table 1


Inclusion and exclusion criteria.
deeply and, thereby reducing breathlessness.
Studies have investigated the effects of diaphragmatic, pursed- Inclusion criteria Exclusion criteria
lip breathing, and yoga breathing, but few were randomized Diagnosis of COPD in medical records Change in medication during the last
control trials (RCTs) [8–11]. For instance, a recent systematic with moderate stage or severe stagea four weeks.
review by Holland et al. [10], based on pooled data from two RCTs at inclusion.
reports that practicing pursed lip breathing gave less breathless- MRC dyspnea scaleb1 at inclusion. Diagnosis of cancer.
Able to read, write, and speak Presently attending a pulmonary
ness. In the same review, one RCT on diaphragmatic breathing and
Norwegian rehabilitation course or other similar
one on yoga breathing showed effects on disease related QOL. All COPD education course.
the said studies were rated as being of low to moderate quality and Attending a competing study.
the results were interpreted as inconsistent, indicating that Diagnosis of neuromuscular disease
or dementia.
additional high quality RCTs are required. In addition, other
Present drug abuse or alcohol abuse.
interventions such as music listening alone and in combination Receiving help from a pulmonary
with breathing control exercises have been found to reduce physiotherapist.
breathlessness in patients with COPD [12]. In order to refine a
Moderate stage and severe stage = FVC < 70% and FEV1%  30% and  80% of
the evidence of BCEs it is important to design breathing control predicted values (FVC = forced volume capacity, FEV1 = forced expiratory volume
trials that control for other interventions that might reduce in 1 s).
b
breathlessness. MRC (Medical Research Council) dyspnea scale measures disabilities associated
with breathlessness using five levels (0–4), where a higher score represents more
Previous studies that employed a biofeedback device to guide
disabilities associated with breathlessness.
the user to breathe more deeply have reported positive effects on
symptoms [13], blood pressure [14], and QOL [13,14] in patients
with heart failure [13] and hypertension [14]. In the biofeedback 2.3. Ethics
device a voice guides the users through air phones/plugs telling
them to follow music tones on inspiration and expiration based on The study was approved by the data protection supervisor of
the respiratory movement, measured with a sensor belt, while the three hospitals and by the Regional Committee for Medical
breathing patterns are stored in the device [15]. Research Ethics for Southern Norway (reference number: 2010/
Such device-guided breathing control based on musical tones 1521), as well as reported to the Clinical Trials government registry
and instruction has not been investigated in patients with COPD (ClinicalTrials.gov identifier: NCT015120043). The protocol com-
and we hypothesize that it may guide patients to breathe more plied with the Declaration of Helsinki. All participants signed a
deeply and slowly and have positive effects on their breathing written consent before entering the study.
pattern and breathlessness.
In the present study, we performed a three-armed double-blind 2.4. Intervention
RCT to investigate whether subjects in the moderate and severe
stages of COPD reported beneficial effects on breathlessness, QOL, The participants were instructed orally and in writing by a
and their breathing pattern after a four weeks intervention study nurse on how to use the device (RespeRate, InterCure Inc.,
program using device-guided breathing control and at four months New York, USA; www.Resperate.com/MD) [13,15]. The device was
follow-up compared with a group who listened to music and a used for the first time at the hospital for 15 min and later at home,
sham control group who sat still. twice a day (i.e. morning and evening) for four weeks. When using
the device the participants were told to sit down in a comfortable
2. Methods chair with few interrupting elements around them.
During the intervention, the patients used the same device to
2.1. Research design measure their breathing pattern, but different instructions were
given via earphones/earplugs.
We performed a three-armed, parallel group, double-blind, The GDBG group members used the device and received
randomized RCT where the patients were in the moderate or instructions about how to breathe slowly based on their RR, which
severe stages of COPD. The arms comprised a guided deep was measured by a sensor belt that was placed around the waist.
breathing group (GDBG), a music listening group (MLG), and a The device played soft, non-rhythmic music in the background, and
sham group sitting still (SSG). a voice instructed the participants to breathe out while the musical
In total, 150 patients with COPD who had been diagnosed with note lasted during expiration, whereas a new musical note
moderate and severe stages of COPD according to the Global followed during inspiration.
Initiative for Chronic Obstructive Lung Disease criteria participated The MLG group members listened to the same music being
in this study [3]. The patients were enrolled between July 2011 and played in the background as the GDBG group members, but they
September 2013 from outpatient units at three different hospitals were not given any instructions to breathe slowly.
in Oslo, Norway (Hospitals A, B, and C) following similar treatment The SSG members only received an introductory instruction to
procedures. All the participants were offered free transportation to sit down and listen to the same music for 1–2 min, but without any
attend individual appointments at the main hospital A. instructions about breathing or music during the at the rest of the
session.
2.2. Recruitment
2.5. Data collection
At each hospital nurses and doctors were instructed to screen
for and recruit eligible patients with moderate and severe stage A questionnaire booklet covering self-reported outcomes
COPD. Patients were given oral and written information at each related to sociodemographic variables, breathlessness, and QOL
hospital before they consented to be contacted by telephone by the was sent by postal mail. Participants were asked to complete the
researcher or a study nurse to confirm their willingness to questionnaire at home 1–2 days before attending the main project
participate in the study as well as fulfilling the exclusion and hospital at baseline (T1), in the follow up after four weeks (T2) and
inclusion criteria (Table 1). four months after baseline (T3).
184 C.R. Borge et al. / Patient Education and Counseling 98 (2015) 182–190

At T1 the questionnaire was checked for items with non-response groups. Envelopes were prepared and the patients were numbered
and physical tests (i.e. pulmonary function test, blood gas sample) (1–120). The study was randomized with 14 blocks, with 14–16
were performed by the main researcher before the participants were patients in each block and four to six patients in each group. First,
allocated to the assigned group. At T2 and T3 the same physical tests the block was drawn. Next, a coded name from the group was
as baseline were performed by the main researcher who was blinded drawn in each block and put into a sealed envelope.
for group assignment and the questionnaire was checked for items
with non-response by the study nurse. The study nurse called the 2.8. Blinding
participants after two days and then subsequently once a week
during the four weeks intervention period to obtain information The study nurse made sure that the participants and the main
about the RR and the quality of the measured RR. This information researcher received no information about whether the participants
was obtained from the device guided with detailed instruction by had been allocated to guided breathing, music, or sitting still.
the study nurse. The same data collection was performed for all However, the participants were informed that the aim of the
groups (i.e. GDBG, MLG, SSG). project was to test if relaxation, silence, or breathing could change
the experience of breathlessness in people with COPD. The
2.6. Outcomes participants were told not to discuss the content of their device
with the main researcher and such contact with the main
The primary outcome was measured in two ways: relief of researcher was also minimized after they had received the device.
symptoms using the St George’s Respiratory Questionnaire (SGRQ) An external person entered all the data in the statistical software
and reported changes in breathlessness using the Global Rating of and data was not analyzed before the data collection was
Change scale (GRC). The secondary outcomes were scores for completed.
diseases related to QOL (i.e., activity and impact according to the
SGRQ) and the breathing pattern (i.e., TIN, TEX, and RR). 2.9. Power calculation
The SGRQ (four-week version) [16] comprises 50 items that yield
one total score, but it can also be divided into three subcategories: We calculated the sample size using the main outcome variable,
symptoms (i.e., out of breath, coughing, wheeze, and sputum), i.e., the symptom score according to the SGRQ, based on the effects
activity limitation (i.e., breathlessness during various tasks and found in a COPD rehabilitation study [23] where the threshold of
physical activity), and impact of the disease (i.e., how illness and change >4 [24]. We aimed for an expected effect of a difference of
breathlessness affect social, emotional, and family life). The ranges of eight points between groups, standard deviation (SD) of 16,
the scores were 0–100, where a high score indicated more significance level of 5%, and a power of 80%; thus, we estimated a
limitations. The SGRQ has been tested thoroughly to confirm its necessary sample size of 150 in total, with 50 in each group. We
reliability and validity in previous studies [17]. In the present study, oversampled each group by 20 patients (total n = 210), but stopped
Cronbach’s alpha was 0.79 for the symptom score, 0.82 for the inclusion at n = 150 because of difficulties recruiting more patients.
activity score, 0.89 for the impact score, and 0.90 for the total score.
The GRC scale was applied to assess change in breathlessness. 2.10. Analysis
The GRC scale was chosen because it is simple, easy to understand
for patients and gives responders the opportunity to quantify their SPSS statistical package version 22 (SPSS Inc, Chicago, IL, USA)
evaluation of improvement over time [18] with regard to was used to perform the analyses. Descriptive analyses were
breathlessness. We asked whether the participants experienced performed for sociodemographic and clinical variables, and for the
a positive change in breathlessness after using the device for four scores obtained using the questionnaires. Analysis of covariance
weeks and at the four months follow-up, on a numeric rating scale (ANCOVA) was used to assess differential changes between groups
anchored 0–10, where 0 = no change and 10 = a high degree of from T1 to T2 and T1 to T3, while controlling for the T1 values
change. A similar instrument called the vertical visual analogue (General Linear Model procedure in SPSS). Paired Student’s t-tests
scale (VAS) is known to be valid for measuring dyspnea in asthma were used to assess changes within groups from T1 to T2 and T1 to
and COPD patients [19]. The NRS and VAS are highly correlated, but T3. Wilcoxon signed ranks test was performed when criteria of
NRS is recommended because it is easier to use [20]. normally distributed variables were not met. ANOVAs were used to
The RespeRate breathing device used in the study [15] assess possible differences in the means between groups at T1. We
comprised a belt-type respiration sensor and a computerized used the first measured variables from the first session and last
control unit. The system analyzed and stored detailed data for the session for TIN, TEX and RR in the analyses. An intention-to-treat
breathing pattern variables, i.e., RR, TIN, and TEX (per minute analysis (last carry forward) was performed (i.e. n = 8 at T2 and
during each 15-minute session), the number of sessions, and the n = 16 at T3 for the SGRQ symptoms score, n = 12 at T3 for GRC
breath detection results for the members of all the groups. scale). These analyses included x–y additional subjects (depending
Specialized software was prepared for the MLG and the SSG groups. on outcome) and revealed only marginal differences in the mean
The measures of breathing pattern variables were available during outcomes, with identical conclusions regarding p-values to the
the period between T1 and T2. analyses performed as standard protocol. Thus standard protocol
The lung function values (i.e., forced vital capacity (FVC), forced results have been reported in our tables. Interaction analyses were
expiratory volume per second (FEV1), the ratio of FEV1/ performed for the main outcomes to test whether the effect of the
FVC = FEV%, and the vital capacity) [21] were measured by intervention differed significantly between specific subgroups of
spirometry (MasterScreen Bodyplethysmography, Jaeger, patients as defined by age, gender, infection, smoking status, COPD
Germany) and the blood gases were sampled (i.e., pressure of stage, co-morbidities and living status. The interaction terms were
oxygen (PO2) and pressure of carbon dioxide tension (PCO2) [22]; entered one at a time in the ANCOVAs while retaining the main
Roche OMNI C, Mannheim, Germany). effects in the model. We calculated and interpreted effect sizes
according to Cohen [25]. The differences within groups were
2.7. Randomization calculated by dividing the mean changes by the average SD at T1
and T2, and T1 and T3, respectively, and between groups by
A person who was not involved in the project was responsible dividing the difference of the mean changes in the experimental
for randomizing the participants into the GDBG, MLG, and SSG and the control groups by their average SDs.
C.R. Borge et al. / Patient Education and Counseling 98 (2015) 182–190 185

3. Results comorbidities was significantly lower in the MLG compared to


GDBG and SSG at T1 (p < 0.05).
3.1. Patient enrollment
3.3. Effect of deep breathing
Among 341 patients who were eligible, 150 patients (44%
response rate) with moderate or severe stages of COPD agreed to 3.3.1. Primary outcomes
participate and were randomized. There was statistically significant within-group decrease in the
The randomization procedure allocated 51 patients to the GDBG SGRQ symptom score (p  0.05–0.001) in all the groups from T1 to
group, 50 patients to the MLG groups, and 49 patients to the SSG T2, and for MLG and SSG (p  0.05–0.001) from T1 to T3. There
group. During the four-week intervention, two patients dropped out were no significant changes in the SGRQ symptom scores between
from each of the GDBG and MLG groups, whereas three patients groups from T1 to T2 and from T1 to T3.
dropped out from the SSG group. Four of these patients turned in The GRC scale for breathlessness detected a significant positive
their device, but data from these were not considered in the analysis. difference with GDBG (p = 0.03) at T2. At T3 the GRC scale GDBG
Seven patients in the GDBG group, eight patients in the MLG was significantly different from MLG (p = 0.04), whereas there
group, and five in the SSG group were lost to follow-up at four months were no significant differences when GDBG was compared to SSG
after baseline. Four of these patients turned in their questionnaire by (not reported in table).
postal mail. These patients received the intervention and are No strong systematic interaction effects were found between
therefore included in the analysis of subjective outcomes. groups on the primary outcome (i.e. symptom score T2 and gender
Fig. 1 shows further information. (eta square = 5%), GRC scale and gender T3 (eta square = 7%)).
All the three groups used the device an equal number of times in
terms of the mean number of sessions conducted during the four 3.4. Secondary outcomes
weeks: the GDBG group with a mean of 50.3 times (SD = 10.5), the
MLG group with a mean of 49.2 times (SD = 11.6), and the SSG For the activity score and the total SGRQ score, there were no
group with a mean of 50.8 times (SD = 10.2). significant differences between groups at T1 and no significant
changes between groups at T2 and T3. Further information is
3.2. Demographic and clinical characteristics provided in Table 3.
For the whole GDBG group, the mean percentage following the
Table 2 shows the clinical characteristics of the participants at instructions given by the device was 53.3 (SD = 23). For all groups
baseline. Predicted lung function is significantly higher in the SSG there were no significant differences between groups of the sensor
compared to GDBG and MLG (p < 0.05). Further number of recognizing the breathing pattern.

Fig. 1. Flow diagram of enrollment.


186 C.R. Borge et al. / Patient Education and Counseling 98 (2015) 182–190

Table 2
Demographic and clinical variables at baseline n = 150.

Variables All participants n = 150 Guided deep breathing Music listening group Sitting still group (SSG)
group (GDBG) n = 51 (MLG) n = 50 n = 49

n (%) Mean (SD) n (%) Mean (SD) n (%) Mean (SD) n (%) Mean (SD)

Age 67.4 (9.0) 67.2 (9.9) 68.4 (8.2) 66.6 (8.9)


Gender
Male 75 (50) 23 (45.1) 30 (60) 22 (44.9)
Female 75 (50) 28 (54.9) 20 (40) 27 (55.1)
Living status
Living alone 81 (57) 30 (63.8) 26 (56.5) 25 (51)
Living with someone 61 (43) 17 (36.2) 20 (43.5) 24 (49)
Education
Primary school 34 (25.6) 13 (30.2) 10 (21.3) 11 (25.6)
Vocational school 18 (13.5) 7 (16.3) 5 (10.6) 6 (14)
Secondary school 38 (28.6) 12 (27.9) 16 (34) 10 (23.3)
University < 4 years 27 (20.3) 6 (14) 11 (23.4) 10 (23.3)
University > 4 years 16 (12) 5 (11.6) 5 (10.6) 6 (14)
Smoking
Yes 60 (40.3) 23 (45.1) 15 (30.6) 22 (44.9)
No 89 (59.7) 28 (54.9) 34 (69.4) 27 (55.1)

Infection in the last four weeks


Yes 26 (17.3) 7(13.7) 9 (18) 10 (20.4)
No 124 (82.7) 44 (86.3) 41 (82) 39 (79.6)
Use of breathing exercises
Yes 55 (37.7) 21 (43.8) 17 (34) 17 (35.4)
No 91 (62.3) 27 (56.3) 33 (66) 31 (64.6)
Pulmonary function
FEV1 predicted 57.6 (17.0) 55.4 (15.1) 54.6 (18.6) 62.7 (16.2)*
RV predicted 178.4 (45.5) 182.2 (49.2) 186.4 (45.8) 166.7 (39.2)
VC predicted 84 (28.2) 82.5 (16.7) 83.2 (20.1) 86.1 (18.1)
COPD stage
Moderate stage 97 (65.1) 31 (60.8) 26 (53.1) 40 (81.6)
**
Severe stage 52 (34.9) 20 (39.2) 23 (46.9) 9 (18.4)
Blood gas analysis
PO2 9.6 (1.3) 9.4 (1) 9.6 (1.4) 9.7 (1.5)
PCO2 5.3 (0.8) 5.2 (0.5) 5.4 (0.8) 5.3 (0.9)
Years with COPD 6.1 (6.1) 6.8 (6.9) 6.3 (6.4) 4.3 (1.8)
Number with comorbidity 3.9 (1.9) 4.3 (1.9) 3.1 (1.6)* 4.3 (1.8)*
*
Significant difference between groups, p < 0.05 according to ANOVA.
**
Significant difference between groups, p < 0.01 according to Pearson Chi-Square.

At T1, there were significant differences between groups in were able to change their breathing pattern by breathing more
terms of RR, TIN, and TEX (p  0.001), with positive effects in the slowly, thereby decreasing their RR and they reported a perceived
GDBG group. change in breathlessness for the GRC scale. An improved breathing
There were also significant changes in RR (p  0.001) and TEX pattern may lead to reduced sympathetic activity [26] and
(p  0.001) between groups from T1 to T2 at the start and at the end strengthen the baroreflex to improve breathlessness [11]. The
of sessions, with positive effects in the GDBG group. There was a breathing patterns were improved in the GDBG members from their
significant change for TIN end of session (p  0.001) in favor of first session until their last session, which showed that the patients
GDBG, but not for TIN start of session between groups from T1 to T2. appeared to have learned how to breathe slowly. Our results may
Further information is provided in Table 4. justify recommending guided deep breathing by use of a biofeed-
back system as an appropriate self-management support procedure
4. Discussion, limitations and conclusion that could help people with moderate and severe stage of COPD to
take more control over their ineffective breathing pattern and
To the best of our knowledge, this is the first three-armed impairment due to breathlessness. However, we found limited
double-blind RCT to evaluate the relief of breathlessness using effects on breathlessness in the GRC scale at four months follow-up,
nonpharmacological interventions of device guided breathing for indicating that continued long-term instructions are needed in order
patients in the moderate or severe stages of COPD. We found that to achieve an optimal performance of the exercise. A device might
all the groups (i.e., GDBG, MLG, and SSG) exhibited changes in their then be more practical to use in a home situation and pulmonary
symptom scores during the four-week intervention but there were training programs than guided instruction by a health person.
no differences in the effects on the symptom scores between the Although the global rating scale showed effect between
groups. We also detected a significant positive effect in terms of the groups, there were no differences between the groups in terms
question that evaluated changes in breathlessness after using the of the SGRQ symptom score. Other studies have reported
device and there was a positive effect on the breathing pattern in differences between groups using the same outcome measure
the guided deep breathing group. in breathing control studies. For example, Katiyar et al. [27]
reported a positive effect of yoga breathing according to all the
4.1. Discussion SGRQ scores. In addition, Yamaguti et al. [28] detected a difference
in the total SGRQ score where there was a positive effect of
Although, there was no significant effect for the SRGQ symptom diaphragmatic breathing compared with a usual care group. We
score, our study demonstrated that the patients in the DGBG group found that breathlessness was reduced in all of our study groups in
Table 3
Mean scores according to St George’s Respiratory Questionnaire (SGRQ) and a numerical rating scale (NRS). Differences between GDBG MLG, and SSG were tested by ANCOVA using the baseline as a covariate. Reported changes in
breathlessness, symptoms, and quality of life (QOL) were estimated at two time points.

Outcomes Group n Baseline After four Cohen Cohen between p-value n Baseline After four Cohen between Cohen between p-value T1–T3
(T1)Mean weeks (T2) between GDBG and MLG, T1–T2 (T1)Mean months (T3) T1 and T3 GDBG and MLG, (whole model)
(SD) Mean (SD) T1 and T2 GDBG and SSG (whole (SD) Mean (SD) and GDBG and SSG
model)

C.R. Borge et al. / Patient Education and Counseling 98 (2015) 182–190


Main outcome variables
Reported change in GDBG 46 NM 3.2 (2.9) 45 NM 2.8 (3.1)
breathlessness after MLG 48 NM 1.8 (2.4) 0.53 42 NM 1.5 (2.4) 0.48
using the device SSG 45 NM 1.9 (2.9) 0.45 0.03a 43 NM 2.4 (3.2) 0.13 0.1b
(GRC scale)#

Symptom score## (SRGQ) GDBG 48 57.4 (21.8) 52.1 (21.9)* 0.24 45 57.3 (22.3) 56.1 (26) 0.05
MLG 47 56.4 (21.8) 48.4 (21.1)** 0.37 0.13 45 54.9 (24.5) 50.3 (24.5)** 0.19 0.13
SSG 45 50.2 (24.7) 45.3 (26.6)* 0.19 0.02 0.6 42 49.8 (25.4) 46.0 (27.3)* 0.14 0.10 0.5

Secondary outcome variables:


Activity score## (SRGQ) GDBG 47 63.5 (19.3) 63.8 (20.2) 0.02 0.2 46 63.1 (19) 63 (21) 0.01 0.1
MLG 48 64 (18.8) 62.2 (21.3) 0.09 0.10 43 64.3 (18.7) 60.9 (21.9) 0.17 0.15
SSG 46 56.3 (21.6) 52.8 (24.4) 0.15 0.17 42 55.8 (21.4) 50.4 (22.9)** 0.24 0.24

Impact score## (SRGQ) GDBG 48 40.4 (22.7)c 39.6 (23.2) 0.04 46 39.5 (22)c 39.9 (24.1) 0.02
MLG 48 37.9 (20.0) 35.4 (18.3) 0.13 0.08 44 37.1 (19.9) 33.7 (19.5) 0.17 0.17
SSG 45 29.3 (20.5) 28.4 (17.6) 0.05 0.01 0.5 42 28.4 (20.4) 28.7 (17.2) 0.02 0.01 0.2

##
Total score (SRGQ) GDBG 47 49.8 (19.7) 48.5 (20.3) 0.07 46 49.4 (19.3) 49.7 (21.6) 0.00
MLG 47 48.9 (18.3) 46 (17.6)* 0.16 0.08 43 48.4 (18.1) 44.9 (18.7)* 0.19 0.18
SSG 46 40.3 (19.6) 38.3 (19.6)d 0.10 0.04 0.5 41 39.8 (19.7) 37.6 (18.9) 0.11 0.11 0.1

GDBG = guided deep breathing group; GRC = global rating change MLG = music listening group; NM = not measured; RR = respiratory rate; SSG = sitting still group; SGRQ = St George’s Respiratory Questionnaire.
*
Significant difference within group from baseline, p  0.05.
**
Significant difference within group from baseline, p  0.001.
#
Higher score = higher degree of positive change. Possible score from 0–10.
##
Higher score = higher degree of problems. Possible score from 0–100.
a
t-test and ANOVA between groups at T2.
b
t-test and ANOVA between groups at T3.
c
Significant difference at baseline between GDBG and SSG, p < 0.05.
d
Non-parametric test p < 0.05, t-test non significant.

187
188 C.R. Borge et al. / Patient Education and Counseling 98 (2015) 182–190

Table 4
Mean scores for the breathing pattern variables (respiratory rate, RR; time on inspiration, TIN; and time on expiration, TEX). Differences between GDBG, MLG, and SSG were
tested by ANCOVA using baseline as a covariate. Changes in the breathing patterns were measured at one time point.

Respiratory pattern Group n Baseline (T1) After four Cohen between Cohen between p-value T1–T2
obtained using the device mean (SD) weeks (T2) T1 and T2 GDBG and MLG, (whole model)
mean (SD) and GDBG and SSG

RR start of session GDBG 49 16 (5.1) 13.4 (5.6)** 0.48


MLG 48 18.5 (5.4) 18.3 (5.6) 0.04 0.43
SSG 46 16.8 (4.9) 16.6 (4.9) 0.04 0.46 0.00a
RR end of session GDBG 49 11.8 (5.1)# 9 (5)** 0.55
MLG 48 17.9 (5.3) 17.6 (4.9) 0.06 0.50
SSG 46 16.6 (4.9) 17.3 (5) 0.14 0.70 0.00a
TIN start of session GDBG 49 1.5 (0.5) 1.9 (1.1)** 0.50
MLG 48 1.4 (0.8) 1.4 (0.6) 0 0.47
SSG 46 1.4 (0.7) 1.7 (1.3) 0.3 0.08 0.06a
TIN end of session GDBG 49 2.3 (1.4)# 2.9 (1.9)** 0.36
MLG 48 1.3 (0.4) 1.4 (0.6) 0.20 0.40
SSG 46 1.4 (0.4) 1.3 (0.4) 0.25 0.61 0.00a
TEX start of session GDBG 49 2.7 (1.3) 3.4 (1.6)* 0.48
MLG 48 2.2 (1.0) 2.2 (0.9) 0 0.56
SSG 46 2.5 (0.8) 2.5 (1.4) 0 0.47 0.001a
TEX end of session GDBG 49 4.3(2.4)# 5.5 (2.5)** 0.49
MLG 48 2.4 (0.9) 2.3 (1) 0.11 0.74
SSG 46 2.6 (1.2) 2.6 (1.2) 0 0.65 0.00a

GDBG = guided deep breathing group, MLG = music listening group, SSG = sitting still group.
#
Significant difference between groups at baseline, p  0.001.
*
Significant difference within group from baseline, p  0.05.
**
Significant difference within group from baseline p  0.01.
a
Significant positive effect of GDBG.

terms of the symptom score. There could be several explanations may have allowed patients time to become more aware of their
for this result. breathing and how to relax. This awareness may also have affected
Firstly, our results showed that the participants were only able their responses to symptoms [32]. Biofeedback devices such as
to synchronize with a mean of 53.3% (recommended value 50–99%) those used in our study are known as mind–body therapies, which
[29] with a large SD of 23. This demonstrates that some of the affect the awareness of changing bodily functions and this might
participants probably could not perform the exercise. We may lead to the cognition of subjective change [33]. Deep breathing
speculate that this may be due to physical barriers such as reduced breathlessness in the GDBG group but it also stimulated
physiological changes in the diaphragmatic muscles resulting in an mucus mobilization and resulted in less coughing according to the
abnormal asynchronous thoracic abdominal motion, which may symptom score. Deep breathing combined with ‘‘huffing’’ is used
limit the possibility of deep breathing [26]. Further may this give often in techniques such as active breathing cycles [34]. We found
difficulties to synchronize the breathing with the instruction given that the effect sizes between T1 to T2 and T1 to T3 were low to
through the device. Another barrier for synchronizing might be a moderate [25], thereby indicating that more research is needed.
lack of understanding [30] of the instruction given from the device. Fourthly, we controlled for attention by calling the patients
Secondly, breathlessness is a complex subjective experience once each week, thus empathetic support may have affected their
[31], which is extremely difficult to measure in terms of its awareness and changed the symptom scores. Empathetic support
characteristics and intensity, thus numerous instruments have may predict adjustment to chronic illness and it also is associated
been developed trying to describe this phenomenon [20]. The with fewer symptoms in COPD [35,36]. The ‘‘meaning of response’’
SGRQ might not have been the best instrument to capture the has been proposed as a mechanism for explaining the placebo
differences between groups in our study. Unidimensional tools effect that arises in the relationship between patients and health
such as the NRS have been shown to be easy to answer and professionals in RCTs [37]. RCTs are viewed widely as providing the
sensitive to changes, thus they are considered to be more suitable strongest evidence when assessing the efficacy of treatment and
for use [20]. In our study, we focused explicitly on the performance care interventions, and they are treated as the gold standard for
of the intervention and we obtained information about how the evaluation in the context of evidence-based medicine. However,
participants felt about the changes in their breathlessness during the status of RCTs has been disputed, partly because of problems
the study. GRC scales have been shown to obtain different results related to the establishment of suitable control groups [38].
where the minimal clinically important difference ranges from All the four groups may have been subjected to mind–body
1.3 to 2 points [18]. Our study detected a difference of 1.3–1.4 therapies that involved conscious mental processes, which may
between the GDBG and the other two groups (MLG and SSG). We have affected bodily functions and possibly the symptom scores.
did not determine the minimal clinically important difference in This means that not only GDBG may be a self-management
patients with COPD, but we may conclude that the patients in the procedure, but also listening to music and relaxation may be used
GDBG reported the relief of breathlessness. The global rating as self-care to give improvement of COPD related symptoms such
question also detected a moderate effect size [25]. as breathlessness in people with moderate and severe stage of
Thirdly, there were also positive changes in the symptom COPD.
scores in the groups listening to music and sitting still, which
might have been attributable to a distracting stimulus directing the 4.2. Limitations
attention away from negative symptoms, as described in reviews
[11,12]. Thus, the SSG with a sham device can also be interpreted as There are several limitations to this study. For example, the
a meditation intervention. Sitting still for 15 min twice per day use of a global rating change scale that ranged from 5 to 5 rather
C.R. Borge et al. / Patient Education and Counseling 98 (2015) 182–190 189

than 0–10 to rate breathlessness might have yielded more Funding


information regarding possible negative changes [18]. Although,
the participants were not informed of the group to which they had This project was supported financially by the Norwegian Extra
been assigned, they may have suspected having been randomized Foundation for Health and Rehabilitation through EXTRA funds, the
to a control group (i.e. MLG, SSG). However, since all the groups Norwegian Nurses’ Organisation (NNO) for the pulmonary nurses in
improved significantly on the symptoms score at the first follow- the NNO, the Norwegian Heart and Lung Patient Organization, the
up, we believe that most of the patients were not aware of their University of Oslo Department of Health Sciences, and the main
actual group assignment. project hospital; Lovisenberg Diaconal Hospital.
The study nurse checked the questionnaires for missing
responses at T2 and T3. She was also the nurse who handed the Competing interest
device to the participants at T1, thus she could have influenced the
participants’ responses in the questionnaires. However, the None declared.
questionnaires were completed at home by the patients before
they attended their hospital appointments and the information Acknowledgments
given to the participants was stored safely. Thus, we consider that
the study nurse could only have had a limited effect on the We acknowledge the participants in the study.
responses in the questionnaires. The study nurse also called the
patients each week to investigate compliance by asking questions
about breathing pattern read out from the device. This may have References
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