JSAFOG Ashwini Chougala, Arati Mahishale 10.5005/jp-journals-10006-1346 RANDOMIZED CLINICAL TRIAL A Randomized Clinical Trial to evaluate the Effect of Therapeutic Ultrasound and Low-level Laser Therapy on Perineal Pain following Vaginal Delivery with Episiotomy 1Ashwini Chougala, 2Arati Mahishale ABSTRACT Source of support: Nil Background and objectives: Vaginal delivery has an enormous Conflict of interest: None amount of pressure on the perineum, the area between vagina Date of received: 19 June 2015 and anus, which must stretch to accommodate the baby’s head during its passage through the birth canal. During childbirth, the Date of acceptance: 31 August 2015 perineum may tear or the obstetrician may decide to incise to make wider opening for baby’s head to pass, a procedure called Date of publication: December 2015 as episiotomy. The area of episiotomy may be uncomfortable and painful for several days. The present study aimed to INTRODUCTION evaluate the effect of therapeutic ultrasound and low-level laser therapy (LLLT) on perineal pain following vaginal delivery with Episiotomy is also called as perineotomy, which is one 1 episiotomy. of the most common procedure performed on women. It is surgically planned incision on perineum and the Materials and methods: Sixty women, who underwent 2 vaginal delivery with episiotomy, complaining of perineal posterior vaginal wall during second stage of labor. pain were recruited and randomly allocated to two treatment The worldwide episiotomy rate is about 27, and 54% are groups. Physiotherapy intervention included cryo gel pad and nulliparous and 6% are multiparous women.3 Episiotomy therapeutic ultrasound in group A and cryo gel pad and low- was first described by Sir Fielding Ould in his Treatise level laser therapy in group B once daily for 3 consecutive days. of Midwifery in 1742, when perineal incision was Outcomes: Measures were documented using visual analog used to facilitate deliveries.4 Traditionally, episiotomy scale (VAS) for pain and REEDA scale (redness, edema, was believed to prevent perineal damage, urinary ecchymosis, discharge, approximation) for healing on 1st day incontinence, anal incontinence, pelvic floor relaxation preintervention and 3rd day postintervention respectively. and protect the newborn from intracranial hemorrhage Results: The study results showed that there was statistically and intrapartum asphyxia.5 significant improvement postintervention in both the groups In normal vaginal delivery, women suffer from with p < 0.05, although therapeutic ultrasound with cryo gel pad showed better reduction in pain score and healing process as perineal trauma which is a significant problem that compared to low-level laser therapy. causes pain and discomfort during the postpartum period. Perineal loss of integrity may cause postpartum Conclusion: Therapeutic ultrasound with cryo gel pad can be discomfort and may negatively influence psychological used to reduce perineal pain following vaginal delivery with 6 episiotomy. and physical function, especially pain. Episiotomies provoke a greater loss of blood and increase the incidence Keywords: Cryo gel pad, Episiotomy, Low-level laser therapy, of dyspareunia and perineal pain after birth.7,8 Pain causes Therapeutic ultrasound. stress and hampers the women’s ability in infant care.9,10 How to cite this article: Chougala A, Mahishale A. A The majority of women who deliver vaginally experience Randomized Clinical Trial to evaluate the Effect of Therapeutic some degree of pain following delivery usually related Ultrasound and Low-level Laser Therapy on Perineal Pain 11 following Vaginal Delivery with Episiotomy. J South Asian Feder to the type and extent of the trauma. Perineal pain Obst Gynae 2015;7(3):152-156. interferes in daily activities of post episiotomy mothers and as well as early bonding of mother and baby. One of the greatest challenges of the physiotherapist is to provide 1Lecturer, 2Associate Professor comfort to such clients. 1,2Department of OBG Physiotherapy, Institute of Physiotherapy Various intervention are found to reduce episiotomy KLE University, Belagavi, Karnataka, India pain and enhance healing process, which include Corresponding Author: Ashwini Chougala, Lecturer administration of analgesics, cleanliness, applying Department of OBG Physiotherapy, Institute of Physiotherapy ice pack, topical application by dry heat (infra red KLE University, Belagavi, Karnataka, India, e-mail: therapy), sitz bath, Kegel’s exercise and perineal care.12 [email protected] Therapeutic ultrasound and low-level laser therapy are 152 JSAFOG A Randomized Clinical Trial to evaluate the Effect of Therapeutic Ultrasound and Low-level Laser Therapy also used to treat perineal pain following episiotomy with was 5 minutes a day for 3 days in lithotomy position low evidence.13,14 Two controlled trials of therapeutic using ultrasonic gel with indirect contact method ultrasound for perineal trauma were reported by Mc using water filled glove. Learn in 1984, Creates in 1987 and they suggested that • Group B: Cryo gel pad and low-level laser therapy: reduction in pain is associated with active treatment. This regime consisted of application of cryo gel pad Also, studies are done to evaluate the individual effect of to perineal area for 10 minute and followed by low- cryo gel pads, therapeutic ultrasound and low-level laser level laser therapy with wavelength of 660 nm, energy therapy (LLLT) to reduce perineal pain and discomfort, density of 3.8 J/cm2 and radiant power 15 mW for but no studies have compared the effectiveness of 30 seconds at perineal area once a day for 3 days in therapeutic ultrasound and low-level laser therapy on lithotomy position. perineal pain after episiotomy. Hence, the present study was designed to evaluate Outcome Measures the effectiveness of therapeutic ultrasound and low-level The outcome measures for pain was visual analog scale laser therapy for perineal pain following vaginal delivery (VAS) and healing process was measured by REEDA with episiotomy. scale.15 The REEDA scale consists of five major assessments MATERIALS AND METHODS area. Each assessment area will be given a minimum Subjects and Study Design score of 0 and maximum score of 3. The total REEDA score ranged from 0 to 15. As the score increases, it will Sixty participants from maternity wards of tertiary care indicate higher rate of infection. If the score decreases, centre with complaint of perineal pain following vaginal it shows the evidence of healing process. Visual analog delivery with episiotomy were recruited by probability scale and REEDA scores were measured on day one pre sampling design (simple random sampling with lottery intervention and day third postintervention. method). They were randomly allocated to two groups, i.e. group A and group B using the envelope method. STATISTICAL ANALYSIS Inclusion criteria were: (1) age group 18 to 35 years, (2) women who complains of pain after 12 hours of normal Statistical analysis was done using statistical software vaginal delivery with episiotomy, (3) primiparous women Statistical Package for Social Sciences (SPSS) version 10. and multiparous women, (4) participants who are willing Various statistical measures, such as mean and standard to participate in the study. Exclusion criteria were: (1) deviation (SD), were used. Wilcoxon-signed rank test postpartum hemorrhage, (2) psychiatric problems. (3) was used as test of significance for outcome measure of women with diabetes and pre-eclampsia and (4) febrile visual analogue scale within the groups. Mann-Whitney conditions. z test was used to test the significant difference in the outcome measure of visual analog scale between groups Procedure A and B. Unpaired t-test was used to find the significant difference in the outcome measure of REEDA Scale All participants were screened for their inclusion and between groups A and B. Paired t-test was used to find exclusion criteria before their recruitment in the study. A the significant difference in the outcome measure of written informed consent was obtained from the study REEDA scale within the groups. The level of significance participants. Participants were allocated to two groups: was set at p < 0.05. group A and group B using envelop method. Baseline data were collected using VAS and REEDA (redness, Age and Body Mass Index edema, ecchymosis, discharge, and approximation) scale prior to the intervention. There was no significant difference between the mean age and body mass index (BMI) of the participants in both the Intervention Table 1: Age and BMI distribution Group A • : Cryo gel pad and therapeutic ultrasound: Age (years) BMI (kg/m2) This regime consisted of application of cryo gel Group A 23.4 ± 3.92 23.2 ± 2.72 pad to perineal area for 10 minute and followed by Group B 24 ± 2.06 23.1 ± 3.54 therapeutic ultrasound with a 3 MHz, intensity of t58 0.694 0.023 0. 5 w/c m 2 with pulse interval 1:1. Therapy duration p-value 0.491 0.981 Journal of South Asian Federation of Obstetrics and Gynaecology, September-December 2015;7(3):152-156 153 Ashwini Chougala, Arati Mahishale groups, which shows that the participants’ characteristics A and 6.6 ± 2.38 was in group B with p-value on day in both the groups were well matched (Table 1). three was <0.001 which showed statistically significant difference. The t-value on day one, when compared Visual Analog Scale Score between group A and group B was 1.923 and on day three In the present study, preinterventional average score was 8.841. The p-value on day one was 0.059, which did of VAS in group A was 7.6 ± 1.29 and in group B was not show statistical significance. The change in REEDA 7.6 ± 1.39 on day one with p-value 0.970, which was not score from 1st to 3rd days in group A was 9.4 ± 2.04 and ± statistically significant difference in both the groups. in group B was 6.4 2.13 with p < 0.001, which showed The baseline VAS scores were matched in the two groups.