Comparison of Low-Level Laser Therapy With Cryotherapy in Postpartum Women With Laceration and/or Episiotomy on Perineal and Vulvar Pain Reduction
Phase: NA
Conditions: Episiotomy; Complications, Laceration
Sponsor: Federal University of Rio Grande do Sul

FEDERAL UNIVERSITY OF RIO GRANDE DO SUL 
SCHOOL OF MEDICINE 
GRADUATE PROGRAM IN HEALTH SCIENCES: 
GYNECOLOGY AND OBSTETRICS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
COMPARISON OF LOW-LEVEL LASER THERAPY WITH CRYOTHERAPY 
IN THE IMMEDIATE POSTPARTUM PERIOD OF PARTURIENTS WITH 
FIRST- AND SECOND-DEGREE LACERATIONS AND/OR EPISIOTOMY IN 
REDUCING PERINEAL AND VULVAR PAIN: 
A randomized clinical trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Nº do project GPPG ou CAAE 58569421.5.0000.5327  
 
 
 
PORTO ALEGRE 
04/2024 

METODOLOGIA 
1.1 Delineamento do estudo 
1.2 This is a randomized clinical trial aimed at comparing the effects of 
cryotherapy and low-level laser therapy on postpartum women up to 24 hours 
after delivery. The control group will receive cryotherapy (CG), and the 
intervention group will receive low-level laser therapy (GL). This study was 
randomized by drawing lots, where there was a paper in a black bag with "LLT" 
or "cryotherapy" written on it, and the patient would draw the paper from the bag 
to select the treatment to be applied. A randomized clinical trial is the gold 
standard for an experimental study or clinical trial, allowing the evaluation and 
demonstration of cause-and-effect relationships between various independent 
and 
dependent 
variables 
(SHARMA; 
SRIVASTAV; 
SAMUEL, 
2020). 
Randomization by randomly generated numbers by computer, tables, coin toss, 

and dice games is considered appropriate (SOUZA; SOUSA; SANTOS JR. et al, 
2019). 
1.3 Location and Condict of the Study 
The present study was conducted and validated at the Municipal Hospital of 
Novo Hamburgo, with application carried out by the researcher. 
1.4 Data Collection 
The data collection was performed through Physiotherapeutic Assessment 
(APPENDIX 
A), 
and 
the 
data 
were 
stored 
in 
an 
Excel 
spreadsheet.Amostragem e amostra 
1.4.1 Sampling 
1.4.2 Patients in immediate postpartum vaginal who meet the inclusion criteria. 
1.4.3 Sample 
1.5 The sample consisted of women admitted to a public hospital in the Vale do 
Sinos region who underwent vaginal delivery and experienced some complication 
during delivery, such as episiotomy or first- or second-degree laceration. The 
sample size calculation was based on studies by Santos et al. (2012) and Morais 
et al. (2016), using the StatCalc – Sample Size and Power tool in the EpiInfo 
software. 
1.6 Inclusion and Exclusion Criteria 
1.6.1 Inclusion Criteria 
 

a) Patients who underwent vaginal delivery; 
b) Experienced first- or second-degree laceration; 
c) Underwent episiotomy; 
d) Aged 18 years or older. 
 
1.6.1 Exclusion Criteria 
 
a) Patients who underwent cesarean section; 
b) Presented with gestational diabetes; 
c) With HELLP syndrome; 
d) Experienced immediate postpartum hemorrhage; 
e) Had unstable vital signs in immediate postpartum; 
f) Under 18 years old. 
 
1.7 Operational Definition of Variables 
1.8 1.7.1 Study Factor 
The comparison of two non-pharmacological techniques used for pain and 
edema relief, performed in immediate postpartum up to 12 hours, being evaluated 

before the application of the techniques, immediately after, and reevaluated after 
24 hours. 
 
1.7.2 Main Outcome 
The idea of using non-pharmacological techniques in immediate postpartum is to 
reduce pain, edema, and inflammatory processes, causing greater comfort and 
better recovery in the puerperium. 
a) Primary Outcome 
- Compare the two techniques to assess which is more effective in relieving pain 
and/or edema in immediate postpartum up to 12 hours. 
b) Secondary Outcome 
- Reduce pain and/or edema and promote healing in immediate postpartum. 
1.9 Research Instrument 
 
Cryotherapy was performed using a glove containing crushed ice applied to the 
perineal region for 20 minutes, initiated up to 12 hours postpartum. Patients were 
assessed before application, immediately after application, and again 24 hours 
after application. A glove containing crushed ice was chosen due to its anatomical 
fit and ability to cover the entire perineal region. Francisco et al. (2013) suggest 
that surface ice has the ability to decrease skin and intramuscular tissue 
temperature. Compared to other cryotherapy techniques such as gel and frozen 
pea bags, the ice bag is the most adopted technique for perineal pain relief. The 
application time aligns with the study by Beleza et al. (2016), indicating that 20 

minutes is sufficient time to cause reduction and relief of pain in study 
participants. 
 
Low-Level Laser Therapy (LLLT), like cryotherapy, was applied up to 12 hours 
postpartum, targeting the lesion area. Red light radiation was applied at 3 joules, 
punctually, with a non-contact technique, maintaining a 2 cm distance between 
points. Subsequently, infrared laser was applied using the conventional contact 
technique around the lesion extension, punctually, at 6 joules, also maintaining a 
2 cm distance between points. 
 
The LLLT device used was the DMC Therapy EC, portable, with a li-ion battery. 
The red laser had a wavelength of 660nm (±10 nm) and an emitter power of 100 
mW (±20%). The infrared laser had a wavelength of 808 nm (±10) and an emitter 
power of 100 mW (±20%). 
 
The use of infrared radiation is associated with being a superficial thermal agent, 
used to reduce pain and stiffness, favoring the regeneration of soft tissue injuries 
and skin problems. (KITCHEN; PARTIDGE, 1991; MICHLOVITZ, 1986). 
 
LLLT application should be punctual, applying firm pressure to the tissue area to 
be treated, resulting in higher levels of tissue light flow. This application is 
characterized by the conventional contact technique, whereas the non-contact 
technique involves application around the wound margins. These combined 
techniques ensure better application and absorption of radiation. Application 

should occur around the circumference of the lesion, approximately 1-2 cm from 
its margins, with application points spaced 2-3 cm apart. (KITCHEN, 2003). 
 
The two most common means of LLLT application are characterized by a 
wavelength of approximately 633 nm (red light) and 904 nm (infrared), capable 
of inducing mitochondrial activity and initiating reactions at the cellular membrane 
level, respectively. (KITCHEN, 2003). 
 
Patients underwent evaluation using a questionnaire, the Patient Assessment 
Form, developed by the researcher. Pain and edema were evaluated using the 
Visual Analog Scale (VAS), McGill Pain Questionnaire (MPQ), and REEDA scale 
before, immediately after, and 24 hours after therapy application. 
 
Pain was assessed on a scale of 0 to 10 using the VAS, with 0 indicating no pain 
and 10 indicating maximum pain intensity. 
 
The McGill Pain Questionnaire (MPQ) was used to assess other characteristics 
of pain, not just intensity. This questionnaire captures quantitative measures of 
pain, with established validity and reliability, allowing for discrimination of various 
pain components. The questionnaire consists of 20 items, or groups, with each 
group containing several words from which the patient selects the one that best 
identifies their pain, selecting only one word per group. The groups are 
subdivided into sensory responses to painful experience (Groups 1-10), affective 
responses (Groups 11-15), evaluative responses (Group 16), and miscellaneous 

(Groups 17-20). The questionnaire takes 3 to 4 minutes to complete. (PIMENTA; 
TEIXEIRA, 1996). 
 
Edema was evaluated using the REEDA scale, which assesses inflammatory 
processes and tissue recovery following perineal trauma. Five scar healing items 
are evaluated: redness, swelling, bruising, discharge, and wound edge 
approximation (coaptation). A score of zero to three is assigned to each item 
evaluated by the assessing professional, with a maximum score of 15 indicating 
the worst perineal healing. (ALVARENGA et al., 2015). 
2 DATA COLLECTION PROTOCOL 
Step 1: Contact and presentation to the head responsible of the Obstetrics Center 
and then to the coordinating nurse of the Obstetrics department at the Municipal 
Hospital of Novo Hamburgo. After introducing myself and presenting the project, 
I provided my contact information and made myself available to be called 
whenever there was a patient who fit the sample profile of this study, taking 
responsibility for its implementation. 
 
Step 2: After signing the Informed Consent Form (ICF), a physiotherapeutic 
assessment was conducted with the patient, as per the form in Appendix B. 
 
Step 3: The patient underwent random selection to determine which intervention 
group she would be assigned to. 
 
Step 4: After group assignment, within 12 hours post-vaginal delivery, the patient 
underwent an assessment of edema and pain using available scales (Appendices 
A, B, and C). 
 
Step 5: The randomly determined intervention, either cryotherapy or laser 
therapy, was administered within 12 hours post-immediate vaginal delivery. 

Following the application described in this study, the patient was immediately 
reassessed for pain using the VAS scale. 
 
Step 6: The patient was reassessed 24 hours post-delivery, and pain and edema 
scales were applied. After this period, the patient was discharged. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

APPENDIX A - PHYSIOTHERAPEUTIC EVALUATION FORM 
PHYSIOTHERAPEUTIC EVALUATION FORM 
NAME: 
DATE OF BIRTH: _______________ AGE: 
CITY OF RESIDENCE: 
PHONE: 
EDUCATION: 
OCCUPATION: 
MARITAL STATUS: 
RELATIONSHIP DURATION: 
WEIGHT: __________ HEIGHT: __________ BMI: __________ 
NUMBER OF PREGNANCIES: 
NUMBER OF VAGINAL DELIVERIES: 
NUMBER OF CESAREAN SECTIONS: 
SMOKER: ( ) YES ( ) NO 
ALCOHOL: ( ) YES ( ) NO 
DRUGS: ( ) YES ( ) NO 
PREVIOUS ILLNESSES: 
ILLNESSES DURING PREGNANCY: 
GYNECOLOGICAL SURGERIES: ___________ WHICH: 

ASSOCIATED MEDICATIONS: 
VAGINAL DELIVERY: ( ) EPISIOTOMY ( ) EPISIOTOMY + FORCEPS 
( ) EPISIOTOMY + 1ST DEGREE LACERATION 
( ) 1ST DEGREE LACERATION ( ) 2ND DEGREE LACERATION 
MEDICATIONS USED POSTPARTUM: