Lasers in Surgery and Medicine

Effect of Low-Level Laser Therapy on Pain and Perineal

Healing After Episiotomy: A Triple-Blind Randomized
Controlled Trial
Marina B. Alvarenga, MSc,1 Sonia Maria Junqueira Vasconcellos de Oliveira, PhD,2

Adriana A. Francisco, PhD,2 Flora Maria B. da Silva, PhD,3 Marcelo Sousa,4
and Moacyr Roberto Nobre, PhD, MD5
1
School of Arts Sciences and Humanities of University of Sao Paulo, Sao Paulo, Brazil
2
Department of Maternal Child and Psychiatric Nursing, School of Nursing, University of Sao Paulo, Sao Paulo, Brazil
3
Midwifery Programme, School of Arts, Sciences and Humanities, Public Health Graduate Program, University of
Sao Paulo, Sao Paulo, Brazil
4
Laboratory of Radiation Dosimetry and Medical Physics, Institute of Physics, University of Sao Paulo, Sao Paulo, Brazil
5
Medical School Clinical Epidemiology Unit, Heart Institute (InCor), University of Sao Paulo, Sao Paulo, Brazil

Background and Objective: Episiotomy is associated
with perineal pain and healing complications. The low-level
laser therapy (LLLT) reduces pain and inflammation and
stimulates the healing process. This study aimed to assess
the effect of LLLT on pain and perineal healing after an
episiotomy.
Design/Materials and Methods: A randomized, triple-
blind, parallel clinical trial with 54 postpartum women who
had a spontaneous birth with a right mediolateral episiot-
omy. The women were randomized into two groups: the
experimental group (applications of LLLT n ¼ 29) or the
placebo group (simulated LLLT applications n ¼ 25). Three
sessions of real or sham irradiation were performed at 6–10
hours after normal birth, and the 2nd and 3rd applications
were performed at 20–24 hours and 40–48 hours after the
first session, respectively. Perineal pain was recorded using
a Numeric Scale ranging from 0 to 10 (0 ¼ absence and
10 ¼ worst pain). Perineal healing was assessed using the
redness, oedema, ecchymosis, discharge, and approximation
(REEDA) scale. Both groups were assessed four times: in
each of the three LLLT sessions and at 7–10 days after
normal birth. The groups were compared using the Student’s
t, Mann–Whitney, and Chi-square tests.
Results: There was no significant difference between the
groups regarding perineal healing after LLLT. The perineal pain
scores were statistically higher in the experimental group in the
first assessment and after the third LLLT. There was no
significant difference between the groups related to the perineal
pain scores 7–10 days after normal birth.
Conclusion: The use of LLLT does not provide any benefit
for treating postpartum perineal trauma using these specific
protocol and parameters. Lasers Surg. Med.
ß 2016 Wiley Periodicals, Inc.
Key words: episiotomy; low-level laser therapy;
perineum; postpartum period; pain
INTRODUCTION
Perineal pain is a common morbidity among women who
had vaginal births. It can persist from the two first
postpartum months [1] to up to 1 year [2] and it is closely
linked to the degree of the birth-related perineal
trauma [3], including episiotomy. The rates of this
intervention have been decreasing in Brazil, from 70% in
2006 [4] to 53.5% in 2011–2012 [5], but they are still higher
than those in developed countries (Sweden and Denmark),
where they can be as low as 10% [1]. However, countries
such as Portugal, Poland have episiotomy rates similar to
those found in Brazil [1].
Several methods have been proposed to treat postpartum
perineal pain. Pharmacological methods include oral
administration of acetaminophen [6], rectal analgesia [7],
and topically applied anaesthetics [8]. Non-pharmacological
methods include ultrasound [9], ice-pack applications [10],
and laser applications [11]. Almost all low-level laser
therapy (LLLT) treatments are conducted with red or
near-infrared (NIR) light (600–1100 nm), with an
output power of 1–1,000 mW in a non-heating energy
density (0.1–100 J/cm2) [12]. LLLT is produced by the
irradiation of low level or low powered lasers, applied on
injuries [12]. The LLLT triggers biochemical, bioelectrical,
and bioenergetic effects, increasing blood microcirculation,
Conflict of Interest Disclosures: All authors have completed
and submitted the ICMJE Form for Disclosure of Potential
Conflicts of Interest and have disclosed the following: [The
authors declare no conflicts of interest to disclosure related to the
manufacturer or distributor of the low intensity laser device used
in this study].
Contract grant sponsor: Coordination for the Improvement of
Higher Education Personnel (CAPES) Agency; Contract
grant sponsor: S~ ao Paulo Research Foundation.


Correspondence to: Sonia Maria Junqueira Vasconcellos de
Oliveira, PhD, Department of Maternal Child and Psychiatric
Nursing, School of Nursing, University of Sao Paulo, Av.
Dr. En eas de Carvalho Aguiar, 419, Sao Paulo 05403-000, Brazil.
E-mail: soniaju@usp.br
Accepted 29 June 2016
Published online in Wiley Online Library
(wileyonlinelibrary.com).
DOI 10.1002/lsm.22559

ß 2016 Wiley Periodicals, Inc.

2 ALVARENGA ET AL.
cellular tropism, as well as promoting tissue repair activity
and the formation of new blood vessels [13]. This set of
effects improves wound healing [14,15], decreasing inflam-
matory responses [16], pain [17] and, therefore, the use of
analgesics [13]. These characteristics, combined with
the fact that LLLT procedures are non-invasive and
non-thermal, prompted their use in healthcare.
The proposal for using a low-intensity laser to treat
perineal pain was inspired by the demonstration of the
analgesic effects of this therapy in dental clinical trials [17].
In postpartum care, LLLT may be used as a complementary
practice to enhance perineal healing [18–20] and it has the
advantage of not interfering with breastfeeding [21].
Five clinical studies were conducted to investigate the
effect of LLLT on postpartum perineal pain resulting from an
episiotomy. Three of these studies found that LLLT improved
the healing process [18–20]. A RCT compared irradiation of
therapeutic laser (n ¼ 748) to Bioptron lamp (n ¼ 581), light
emitting diodes (n ¼ 715), and no treatment (n ¼ 592). A
higher effect on episiotomy healing with minimum secondary
complications was achieved after using a therapeutic
laser [18]. The second trial was performed with 86 women
after a perineotomy or an episiotomy investigated the effects
of hydrogen peroxide and potassium permanganate (n ¼ 40)
versus magnet laser therapy (red and infra-red light
combination) plus hydrogen peroxide and potassium per-
manganate (n ¼ 46). The application of laser improved the
process of healing considerably, with rapid disappearance of
inflammatory signs and analgesic effect [19]. The third trial
was carried out with 19 postpartum women with an
episiotomy, comparing three treatments: systemic antibiotics
(n ¼ 7), diode laser therapy plus systemic antibiotic (n ¼ 6),
and diode laser therapy (n ¼ 6). The diode laser therapy
enhanced episiotomy wound healing and induced analgesic
effects [20]. However, some of these studies [18–20] have
unclear methodological aspects, such as the lack of randomi-
zation and lack of standardization of the healing assessment
criteria and LLLT protocols. Moreover, the possible conflicts
of interest between the authors of those studies and the LLLT
device manufacturers have not been disclosed.
A pilot study [11] and a clinical trial evaluating the effect
of LLLT on perineal pain and episiotomy healing [22] did not
find any significant difference in outcome between the
experimental and control groups, due to ineffective irradia-
tion parameters, such as low wavelength, irradiation time,
energy/point, energy/session, power, and total energy.
Considering the results of these previous trials, the present
study was conducted to test the effect of a higher dosage of
laser on pain and perineal healing following an episiotomy.
METHODS
This study was designed as a randomized, triple-blind
parallel clinical trial. The research protocol was approved
by the Ethics and Research Committee of the School of
Nursing, University of Sao Paulo (Approval number
1.006/2011/CEP-EEUSP) and by the Research Ethics
Committee of the University Hospital: University of Sao
Paulo (Approval number CEP-HU/USP 1093/11- SISNEP
CAAE: 0010.0.196.198-11) and registered on the website
Brazilian Register of Clinical Trials (REBEC), with the
UTN number U1111-1120-8464.
Participants
Inclusion criteria were: postpartum women who had a
spontaneous normal birth of a singleton live foetus
(gestational age between 37 and 42 weeks) with a right
mediolateral episiotomy; age  18 years; no previous
vaginal delivery. Exclusion criteria were: postpartum
infection, haemorrhoids, varicose veins or bruises on the
vulvoperineal region; use of perineal massages, pelvic floor
training or application of any substances other than water
and soap on the perineum during the pregnancy and
clinical or obstetric complications.
Eligible women were invited to participate in the study
within 6–10 hours after birth.
Postpartum women who used a product other than soap
and water in the vulvoperineal region or have received anti-
inflammatory medication were excluded from this study.
Setting
The study was conducted in a teaching hospital with
nearly 300 births per month, with a Caesarean section rate
of 50% and a vaginal birth rate of 50%. The intrapartum
care is provided by medical students. Non-evidence-based
interventions are still routinely used in the intrapartum
care offered to women in this service, including perineal
shaving, antepartum enemas, fasting during labor,
amniotomy (artificial rupture of amniotic membranes),
intravenous oxytocin infusion and episiotomy. Postpartum
perineal trauma is classified by the birth attendant as
episiotomy or lacerations. Medicines to treat pain relief are
provided upon request: metamizole (DypironeTM—an
analgesic widely used in South America) and diclofenac
(a non-steroidal anti-inflammatory drug). Healthy women
and their newborns remain together in the postnatal ward
and are generally discharged within 48 hours of birth. An
appointment with a nurse or midwife is set for between 7
and 10 days postpartum, at the clinic outpatient service.
Sample Size
A pilot study was carried out with 50 participants in
order to calculate the current trial sample size, based on
the levels of perineal pain (the primary outcome for this
study, evaluated on a numerical scale 0–10). In prelimi-
nary analysis, we obtained a reduction of two points in pain
score (a mean of 3.4 points and standard deviation of 2.7
was reduced to 1.4 points, with a standard deviation of 1.6).
With an alpha error of 0.05 and a test power of 80%, the
results indicated that each study group should have at
least 25 women. There were no differences between the
study protocols of the pilot study and the present study,
therefore the sample used in the pilot study was included
in this clinical trial.
Women included in the study were randomly assigned to
the experimental or placebo groups following a concealed
allocation with sequentially numbered, sealed and opaque
 A TRIPLE-BLIND RANDOMIZED CONTROLLED TRIAL
envelopes that contained the computer-generated codes for
the experimental group (A) or placebo group (B), until each
group reached the minimum number of 25 participants.
The numbers displayed on the envelops were only used to
ensure that the correct number of women were included in
both groups of the study. The final sample size consisted of
54 women; 29 women in the placebo group, and 25 women
in the experimental group. The four additional women in
the placebo group did not influence the outcomes of the
statistical analysis.
Blinding
A professional statistician who was not involved in the
research prepared the envelopes, which were sequentially
opened by the main researcher immediately before the
LLLT application, to verify the allocation of the partic-
ipants to the groups according to the letter contained in the
envelope. The person who applied the LLLT, the women
who participated in the study, the evaluators who assessed
the outcomes and the statisticians who performed the data
analysis were all blind to the type of intervention. The laser
source had two identical tips that were modified by the
manufacturer to ensure that one of them emitted infrared
laser and the other tip emitted only a guiding light
(because infrared light is invisible to the human eye). The
tips were identified as A and B, and the researcher was not
aware of which tip emitted laser or only the guiding light.
Intervention and Data Collection
The participants were in lithotomic position and any
discharges present in the perineum were removed. The
irradiation was applied by the main researcher on specific
points of the episiotomy, touching the tip of the laser
pointer on nine points of the episiotomy. These points were
equally distributed along the suture and located on the
incision and on the left and right sides of the suture line,
1 cm away from the edges of the episiotomy wound,
regardless of the episiotomy’s length. The irradiation
time for each session was 90 seconds.
Experimental group. In this group, the LLLT applied
had the following characteristics (Fig. 1):
The selection of the energy density used in the
experimental group (5 J/cm2) was based on a previous
study, although the authors used different equipment
to provide LLLT [18]. In this study, the source of
irradiation used was a clinical, portable Low-Intensity
Fig. 1. Low-level laser therapy parameters.
3
TM
Laser device, Twin Laser (MMOpticss Ltda, Brazil),
classified as a class 3B laser with diode as the active
element (Register in the National Health Surveillance
Agency (ANVISA): 80051420007; Certification in the
National Institute of Metrology, Standardization, and
Industrial quality (INMETRO): NCC 2,756/05). To
ensure that the correct power was used throughout
the data collection period, an independent researcher
used a power meter to evaluate the emitted power
regularly (Coherent Inc., Santa Clara, CA).
Placebo group. These women received the same
intervention procedure described above; however, the
researcher used a laser tip modified by the manufacturer
to ensure that the device would not release any laser
irradiation.
In both groups, the women received three sessions of real
or sham irradiation, with intervals of approximately 24
hours before the hospital discharge. The 1st, 2nd, and 3rd
sessions were carried out at 6–10 hours postpartum and
between 20 and 24 hours and 40 and 48 hours after the first
session, respectively. These time periods were chosen in
order to evaluate the possible early and late effects of LLLT
application on postpartum perineal pain and healing. The
laser source tip was cleaned between the sessions of
irradiation with 70% alcohol and wrapped with a flexible
plastic material (PVC Polyvinyl).
Data collection was undertaken from June 6 to October
21, 2011, on all days of the week, from 7 am to 7 pm. We
included women who gave birth from 10 pm of the previous
day to 12 am of the day of LLLT to ensure that the woman’s
inclusion and the first intervention would be performed
from 6 to 10 hours after normal birth.
Outcomes
The primary outcome of the study was the level of perineal
pain, assessed using a scale of 0–10, in which zero indicated
no pain and 10 was the worst imaginable pain. The
participants were asked to rate their pain intensity
according to this scale. Secondary outcomes included wound
healing and the woman’s opinion about the LLLT inter-
vention’s analgesic effect. Wound healing was assessed with
the REEDA scale, which includes the following five items of
healing: redness, oedema, ecchymosis, discharge, and the
approximation of the wound edges. In the evaluation, each
item in the REEDA scale was rated from 0 to 3, according to
the observed intensity of the item. The total points of the
scale ranged from 0 to 15 points. The higher the score, the
worse the perineal condition [23,24]. In this study, redness
was only considered in its extension, even when it was
present on only one side of the incision. To measure the
length of episiotomy and the redness, oedema, ecchymosis,
discharge, and approximation of the wound edges using the
REEDA scale, we used the ruler Peri-RuleTM, which
was specifically designed to assess perineal trauma [25].
The women’s opinions on the LLLT intervention’s
analgesic effect were obtained using a verbal four-point
scale with the following items: very good, good, bad, and
very bad.
4 ALVARENGA ET AL.
Perineal pain and perineal healing were assessed four
times. Pain was assessed immediately before and 30
minutes after the three laser irradiations. Healing was
assessed immediately before the three irradiations and the
fourth healing assessment was performed from 7 to 10 days
after childbirth. The evaluation of the perineal healing was
undertaken by two evaluators, the main researcher and
the secondary researcher, who assessed the outcomes
consecutively and independently from each other. In cases
of disagreement, a third researcher independently
assessed the perineal healing and provided a score to
represent most of the values or the greatest value indicated
by the three evaluators. The researchers who assessed the
outcomes were 11 nurse-midwives from the HU-USP who
were trained by the main researcher to use the REEDA
scale in perineal examinations during their routine work.
After the data analysis, the device program was tested by
pointing the laser beam at the power meter detector. The
laser irradiation power was then verified as 20 mW for the
experimental group (Group A) and 0 for the placebo group
(Group B).
Statistical Analysis
Data were double inserted into the database and checked
for consistency using the statistical package EpiInfo
version 6.04. For statistical analysis, we used the Statisti-
cal Package for Social Sciences (SPSS) version 17.0 for
Windows. Descriptive analysis included calculation of the
mean and standard deviation for the continuous variables
and proportions for the categorical variables. We verified
the adherence of the quantitative variables to the normal
curve with the One-Sample Kolmogorov–Smirnov test.
Student’s t, and Mann–Whitney tests were used to
Fig. 2. Flowchart of the recruitment diagram and study follow-up of the postpartum women.
compare quantitative variables between the groups. The
Holm–Bonferroni correction was used where appropriate.
Qualitative variables were compared with the Chi-square
test. In all statistical analyses, P values <0.05 were
considered statistically significant.
RESULTS
Among women approached for this study, 61 were
eligible and 7 of them were excluded, resulting in 54
women who were randomized into experimental and
placebo groups. Nine women did not attend the follow-up
visits in the institution, and two were excluded from the
study after the hospital discharge because they used anti-
inflammatory medication. Therefore, there was a loss of 11
women (20.4%) during the follow-up. No women were
excluded from the study after the randomization, and there
was no crossover between the experimental and placebo
groups (Fig. 2).
Sociodemographic and clinical variables were used to
characterize the women in the sample and evaluate the
similarity between the study groups (Table 1).
This analysis showed no significant difference between
the groups with respect to the baseline characteristics,
except for the type of anaesthesia used in the intrapartum
period (P ¼ 0.043). There was a higher frequency of spinal
anaesthesia in the placebo group, and a greater number of
local and combined spinal-epidural anaesthesia in the
experimental group.
The comparison between the mean scores of perineal
healing, which was based on the REEDA scale, showed no
significant difference in the four assessments (Table 2).
Table 3 presents data related to the REEDA scale items
in the four assessments.
 A TRIPLE-BLIND RANDOMIZED CONTROLLED TRIAL 5

TABLE 1. Participants and Newborn Characteristics the first three assessments, and it was not present in the
fourth assessment.
Groups
The presence of secretion was observed in two women in
Variable Experimental Placebo the third assessment. In the fourth assessment, two
women in the experimental group had yellow discharge
Maternal age (years) mean 22.6 (5.0) 22.0 (3.5) (pus) on the episiotomy and problems with approximation
(SD) of the skin edges of episiotomy.
Ethnic group n (%) Problems with the approximation of the wound skin
White/Asiatic 16 (55.2) 11 (44.0) edges were observed in two other women, one in each
Black/Mulatto 13 (44.8) 16 (56.0) group, in the first and second assessments.
Education (years) n (%) In the fourth assessment, dehiscence was the most
8 6 (20.7) 5 (20.0) frequent complication. Out of the 51 women, 19 had
9–11 20 (68.9) 17 (68.0) problems of approximation after the hospitalization, 13
>11 3 (10.3) 3 (12.0) had separation of the wound skin edges up to 3 mm (nine in
BMI at admission mean 27.1 (3.2) 27.1 (3.2) the experimental group and four in the placebo group), and
(SD) six had the wound opened down to the subcutaneous tissue
Gestational age mean (SD) 38.6 (1.0) 38.9 (1.3) (three in the experimental group and three in the placebo
Parity n (%) group). Among the three women with problems in the
1 29 (100) 22 (88.0) approximation of the skin wound edges in the hospital,
2 — 3 (12.0) one did not attend the fourth assessment and could not
Anaesthesia n (%) be located via an active search; one postpartum woman
Local 11 (37.9) 4 (16.0) in the placebo group showed improvement, and one
Spinal 11 (37.9) 18 (72.0) participant in the experimental group had a partial
Combined spinal- 7 (24.2) 3 (12.0) dehiscence of the wound.
epidural With regard to the experimental group, there was a
Birth weight mean (SD) 3,168.1 (429.2) 3,061.0 (341.1) significant decrease (P ¼ 0.031) in the number of women
Cephalic perimeter mean 33.9 (1.4) 33.8 (1.2) who reported perineal pain 30 minutes after the second
(SD) LLLT (17 women) when compared to those before
Number of oral analgesic 1.3 (1.7) 0.9 (1.6) the irradiation (23 women). In the following assessments
doses mean (SD) (40–48 hours), there was no significant difference in the
Interval between the oral 289.8 (331.1) 362.1 (260.7) number of women who reported pain before and after the
analgesic use and the LLLT in both groups.
assessment (min) mean The mean of perineal pain levels before and after the four
(SD) assessments is shown in Table 4. The pain levels were
Episiotomy extension (cm) 3.2 (0.9) 3.7 (0.9) different between the experimental and placebo groups in
mean (SD) the first assessment (before and after) and in the third
assessment (only after). These differences indicate higher
pain scores in the experimental group.
In the first assessment, there was an elevated frequency Most postpartum women in both experimental and
of oedema, a low frequency of redness and ecchymosis, and placebo groups (97.8%) considered the procedure very good
no secretion. or good. The volunteers’ answers indicated that many
We found a low frequency of redness in the first (95.6%) would undergo the procedure again in future
assessment, which was slightly increased in the second births, if necessary.
assessment, particularly in the experimental group. There
was a reduction in the redness and oedema observed in the DISCUSSION
third assessment, which were absent in the fourth This study aimed to evaluate the effects of LLLT
assessment. The frequency of ecchymosis was similar in irradiation on pain and healing of right mediolateral

TABLE 2. Comparison of the Mean Total Score of the REEDA Scale in the Evaluated Periods

Groups

Periods Experimental mean (SD) Placebo mean (SD) P-valuea

From 6 to 10 hours (1st) 1.10 (1.61) 0.96 (1.10) 1.000

From 20 to 24 hours (2nd) 1.17 (1.61) 0.84 (1.10) 1.000
From 40 to 48 hours (3rd) 0.83 (1.17) 0.80 (1.35) 1.000
From 7 to 10 days (4th) 0.95 (1.21) 0.48 (0.75) 0.656
a
Mann–Whitney test with Holm–Bonferroni correction.
6 ALVARENGA ET AL.

TABLE 3. Distribution of the Results of the REEDA Scale Items, According to the Experimental and Control
Groups, for the Assessment Periods

Groups

Items and periods of assessment Experimental n (%) Placebo n (%) P-valuea

Redness
From 6 to 10 hours (1st) No 28 (96.6) 24 (96.0) 1.000
Yes 1 (3.4) 1 (4.0)
From 20 to 24 hours (2nd) No 23 (79.3) 23 (92.0) 0.355
Yes 6 (20.7) 2 (8.0)
From 40 to 48 hours (3rd) No 28 (96.6) 23 (92.0) 0.895
Yes 1 (3.4) 2 (8.0)
From 7 to 10 days (4th) No 22(100) 21 (100)
Yes — — —
Oedema
From 6 to 10 hours (1st) No 15 (51.7) 15 (60.0) 0.737
Yes 14 (48.3) 10 (40.0)
From 20 to 24 hours (2nd) No 17 (58.6) 18 (72.0) 0.459
Yes 12 (41.4) 7 (28.0)
From 40 to 48 hours (3rd) No 21 (72.4) 19 (76.0) 1.000
Yes 8 (27.6) 6 (24.0)
From 7 to 10 days (4th) No 22(100) 21 (100)
Yes — — —
Ecchymosis
From 6 to 10 hours (1st) No 25 (86.2) 20 (80.0) 0.807
Yes 4 (13.8) 5 (20.0)
From 20 to 24 hours (2nd) No 24 (82.8) 20 (80.0) 1.000
Yes 5 (7.2) 5 (20.0)
From 40 to 48 hours (3rd) No 24 (82.8) 20 (80.0) 1.000
Yes 5 (17.2) 5 (20.0)
From 7 to 10 days (4th) No 22 (100) 21 (100)
Yes — — —
Discharge
From 6 to 10 hours (1st) No 29 (100) 25 (100)
Yes — — —
From 20 to 24 hours (2nd) No 29 (100) 25 (100)
Yes — — —
From 40 to 48 hours (3rd) No 28 (96.6) 24 (96.0) 1.000
Yes 1 (3.4) 1 (4.0)
From 7 to 10 days (4th) No 20 (90.9) 21 (100)
Yes 2 (9.1) — 0.490
Approximation
From 6 to 10 hours (1st) No 28 (96.6) 24 (96.0) 1.000
Yes 1 (3.4) 1 (4.0)
From 20 to 24 hours (2nd) No 28 (96.6) 24 (96.0) 1.000
Yes 1 (3.4) 1 (4.0)
From 40 to 48 hours (3rd) No 27 (93.1) 25 (100) 0.538
Yes 2 (6.9) —
From 7 to 10 days (4th) No 10 (45.5) 14 (66.7) 0.274
Yes 12 (54.5) 7 (33.3)
a
Chi-square test.

episiotomies after normal birth. Our findings do not
confirm the hypothesis that LLLT improves perineal
healing or pain.
Similar results from a previous study [11] indicated that
after LLLT irradiation, there was no difference between
the scores of episiotomy healing and perineal pain up to
2 hours, 20–24 hours, and 15–20 days after normal birth.
The effects of LLLT on perineal pain following an
episiotomy were also not significant in a Brazilian study
that compared the irradiation of infrared laser, red laser,
 A TRIPLE-BLIND RANDOMIZED CONTROLLED TRIAL 7

TABLE 4. Comparison of the Means and Standard Deviations of Perineal Pain Levels Between Groups Before and
After LLLT

Groups

Assessment Experimental mean (SD) Placebo mean (SD) P-valuea

From 6 to 10 hours (1st) Before 4.5 (3.0) 2.0 (2.2) 0.002

After 4.1 (2.8) 2.0 (2.2) 0.008

From 20 to 24 hours (2nd) Before 3.2 (2.6) 2.1 (2.2) 0.100
After 2.6 (2.7) 1.5 (2.1) 0.156
From 40 to 48 hours (3rd) Before 1.9 (2.5) 1.0 (1.9) 0.125
After 1.5 (2.2) 0.6 (1.4) 0.019

From 7 to 10 days (4th) — 1.2 (2.4) 1.1 (2.4) 0.748
a
Mann–Whitney test.


P-value < 0.05.

and simulation. The comparison among the three groups
showed no significant difference in the mean perineal pain
at any of the three time points [22].
Regarding the REEDA items, we found no significant
difference between the groups in any of the four time
points. Most studies did not assess perineal healing with
this scale, and the evaluation of the effectiveness of the
LLLT application on perineal pain and healing was based
on women’s reports. In a trial [19], an infrared-pulsed
LLLT with a magnetic field to treat postpartum perineal
pain was compared with hydrogen peroxide and potassium
permanganate. After complete healing, women who did not
receive radiation reported a higher frequency of swelling,
pain and redness, and presented with a higher number of
dehiscences [19].
In the current study, although the randomization
protocol was rigorously followed, women received spinal
anaesthesia significantly more frequently in the placebo
group. This difference might explain the difference in the
initial pain intensity between the groups. Conversely, the
reduction in the pain intensity between 6 and 48 hours in
the experimental group was nearly twice that observed in
the placebo group, which was possibly because these
women reported higher levels of baseline pain.
In the current study, the women of the experimental
group were compared with the placebo group. The placebo
was a controlled intervention that was similar to the
intervention under investigation but lacked its major
component. The placebo effect assumes that a result found
in a study group may arise from the interaction between
the researcher and the patient or from the treatment
procedure [26]; for instance, because the patient can feel
safer, change his or her expectations, or reinterpret their
symptoms with treatment initiation [27].
Considering the ethical aspects of the use of placebos, we
chose this design to obtain complete intervention blindness
and thereby reduce the possible biases. The women who
participated in this study were informed prior to its start
that they could withdraw from the study at any time and
were informed of the possibility that they could be included
in either of the study groups. Such informed participation
is named “authorized deception” [28]. All information on
the study was available to the participants, who freely
signed informed consent forms.
To date, there is no evidence supporting the use of LLLT
to treat perineal trauma because it did not affect post-
partum perineal healing or pain. Moreover, no side effects
or harmful effects of LLLT have been described in the
literature. Further research may be necessary to define an
appropriate irradiation protocol to treat post-partum
perineal pain.
The change in the wavelength used in this study protocol
aimed to increase the absorption by cytochromy-c-oxidase,
with wavelengths between 800 and 850 nm instead of
780 nm. The increase in irradiation time should be from 10
to 80 second and from 20 mW Power to 50 mW, will result in
an energy/point of 4.0 J, which is an energy level largely
used in clinical practice to treat wound healing. Therefore,
this improved protocol had a total energy 20 times higher
than that used before, resulting in deeper penetration of
the photons and higher absorption into the mitochondria.
The parameters to improve the protocol used in the current
study are shown in Figure 3 [29–31].
As a limitation of this study, the sample size was not
powered to detect small differences in the REEDA scale
assessment; moreover, these differences would not have
clinical significance. The cost evaluation was not assessed
and one fifth of women were lost during the follow-up.
Furthermore, there are numerous variables for the LLLT
protocols and outcomes that are more effective and could
Fig. 3. Low-level laser therapy parameters.
8 ALVARENGA ET AL.
be determined using other parameters. Additionally,
differences in the skin types of the study participants might
have influenced the outcomes of the LLLT application. In
darker skin types, the parameters for the laser wave-
lengths, pulse durations, and epidermal cooling must be
carefully evaluated to ensure that LLLT is effective [32].
CONCLUSION
There is no current evidence of the benefits of using low-
intensity laser to treat pain and healing after episiotomy
among women who have a normal birth.
ETHICAL APPROVAL
This study was approved by the Ethics and Research
Committee of the School of Nursing, University of Sao
Paulo, with the Protocol number 1.006/2011/CEP-EEUSP.
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