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CTRI Number  CTRI/2025/09/094056 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 31/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Study on breast milk versus sitz bath for episiotomy wound healing in post natal mothers 
Scientific Title of Study   A comparative study to assess the effectiveness of breast milk application versus sitz bath on episiotomy wound healing among post natal mothers in selected community areas of Punjab 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
EC/NEW/INST/2025/531/433, Version 2.0, Date: 16/05/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Timsy 
Designation  Associate Professor 
Affiliation  Chitkara University 
Address  Chitkara School of Health Sciences Department of Nursing Chitkara University Rajpura Punjab
Chitkara School of Health Sciences Department of Nursing Chitkara University Rajpura Punjab
Patiala
PUNJAB
140401
India 
Phone  8699543453  
Fax    
Email  timsy@chitkara.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Prachi Gupta 
Designation  Post Graduate Student 
Affiliation  Chitkara University 
Address  Chitkara School of Health Sciences Department of Nursing Chitkara University Rajpura Punjab
Chitkara School of Health Sciences Department of Nursing Chitkara University Rajpura Punjab
Patiala
PUNJAB
140401
India 
Phone  8082207787  
Fax    
Email  prachigupta2501.don24@chitkara.edu.in  
 
Details of Contact Person
Public Query
 
Name  Prachi Gupta 
Designation  Post Graduate Student 
Affiliation  Chitkara University 
Address  Chitkara School of Health Sciences Department of Nursing Chitkara University Rajpura Punjab
Chitkara School of Health Sciences Department of Nursing Chitkara University Rajpura Punjab
Patiala
PUNJAB
140401
India 
Phone  8082207787  
Fax    
Email  prachigupta2501.don24@chitkara.edu.in  
 
Source of Monetary or Material Support  
Chitkara School of Health Sciences Department of Nursing Chitkara University Rajpura Punjab, India 140401 
 
Primary Sponsor  
Name  Prachi Gupta 
Address  Chitkara School of Health Sciences Department of Nursing Chitkara University Rajpura Punjab, India 140401 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ratan  SITE 1: Community Health Centre Banur SITE 2: Community Health centre Kalomajra  Site 1: Community Health Centre ,Banur, District Patiala, Punjab, India Site 2: Community Health Centre ,Kalomajra,Rajpura, District Patiala, Punjab, India
Patiala
PUNJAB 
9217739015

prachigupta20001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, Chitkara University Punjab  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O901||Disruption of perineal obstetric wound,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Breast milk application  Participants in this group will be instructed to express fresh breast milk and apply it to the episiotomy wound 2 times daily up to 7 postpartum days.  
Comparator Agent  Sitz bath application  Participants in this group will be instructed to take sitz baths with warm water (100-105 degree F), with antiseptic solution (povidine iodine solution), for 15-20 minutes, 2 times daily up to 7 postpartum days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Mothers who are within 24 to 48 hours post-delivery.
2.Mothers who don’t have any underlying medical conditions that could interfere with wound healing.
3.Mothers with an episiotomy wound (simple or intermediate).
4.Mothers who are willing to participate in the study.
 
 
ExclusionCriteria 
Details  1. Mothers who have sustained a perineal tear.
2. Mothers who are diagnosed with any breast complications like mastitis and breast abscess.
3.Mothers who have known allergies or hypersensitivity reactions.
4.Mothers who are diagnosed with complications related to puerperium like puerperal sepsis, Post partum hemorrhage.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Episiotomy wound healing measured using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation)  baseline 3rd day, 5th day and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction: 

 

Episiotomy is a surgical procedure commonly performed during childbirth, involving an incision in the perineum to widen the vaginal opening and facilitate delivery. Postpartum women who undergo episiotomy require effective wound care to prevent complications and promote healing.

 

Among the methods suggested for improving episiotomy wound healing, breast milk application has gained attention due to its antimicrobial, anti-inflammatory, and healing properties. Breast milk is known to contain numerous bioactive compounds such as immunoglobulins, lactoferrin, and lysozymes, which are believed to help reduce infection and promote tissue repair.

 

On the other hand, sitz bath have long been recommended as a soothing treatment to alleviate perineal discomfort, reduce swelling, and promote hygiene following childbirth

A sitz bath, where the perineum is immersed in warm water, is thought to improve blood circulation to the area, reduce pain, and assist in wound healing. Sitz baths are known to help maintain proper hygiene, which is crucial for preventing infection in the postpartum period

 

Need:

Episiotomy is a common surgical intervention performed during childbirth to prevent severe perineal tears, but the healing of the wound remains a critical concern for postpartum recovery. Poor wound healing or complications such as infection, pain, and delayed recovery can significantly affect the health and well-being of new mothers. Traditionally, episiotomy wound care has focused on antiseptic applications, analgesics, and suturing. However, these conventional methods do not always adequately address the need for accelerated wound healing, infection prevention, and pain management. This gap in care has led to increasing interest in alternative and complementary approaches, especially natural and accessible remedies. Two such interventions breast milk application and sitz bath have been identified as potential low-cost, non-invasive methods to promote wound healing, alleviate pain, and reduce the risk of infection

Review of literature:

 

1.      Patel A, Makwana et al. (2022) conducted a quasi-experimental study to assess the effect of Topical Application of Breast Milk on Episiotomy Wound Healing. Sample size was 40 post natal mothers from selected health centers of Central Gujarat, India. Pretest posttest design was used.  Intervention of topical application of breast milk was offered two times a day for seven continuous days in experimental group and routine care was provided to participants in control group. Data was collected using Redness, Edema, Ecchymosis, Discharge and Approximation (REEDA) scale on 1st, 3rd, 5th and 7th day. The result showed that the experimental group’s episiotomy wound healing significantly improved (before: 14.75±0.55, after: 4.55±1.32) as compared to the control group (before: 14.65±0.59, after: 9.35±1.46). The study concluded that here was a significant gradual healing of episiotomy wound after the use of breast milk topically in postpartum women. This also indicates that human breast milk can be an alternative strategy for accelerating episiotomy wound healing process

 

2.      Rani K., Kumar P. et al (2021) conducted an Observational Study to compare sitz bath and alternative treatments for episiotomy wound healing. Sample size was 100 participants who had undergone episiotomy from a maternity ward in Bhopal, Madhya Pradesh, India. Purposive sampling was used to select participants who had undergone episiotomy within 48 hours and were assigned randomly to either treatment group. Data was collected using the REEDA scale and pain scores measured via a 10-point scale were recorded daily. Infection rates were tracked with microbiological swabs. The result showed that the sitz bath group had a mean healing time of 9.7 days (SD = 2.3), while the control group had a mean of 14.3 days (SD = 2.8). The sitz bath group had a pain score of 3.6 (VAS), while the control group had a pain score of 5.9 (VAS). The study concluded that the sitz bath group had faster healing, reduced redness, and lower infection rates compared to the ointment group.

 

 

 

Problem statement

A comparative study to assess the effectiveness of breast milk application versus sitz bath on episiotomy wound healing among post natal mothers in selected community areas of Punjab

Objectives

·        To assess episiotomy wound healing among post natal mothers in both experimental group and comparison group.

·        To compare the effectiveness of breast milk application on episiotomy wound healing among post natal mothers in experimental group and comparison group.

·        To compare the effectiveness of sitz bath on episiotomy wound healing among post natal mothers in experimental group and comparison group.

·        To compare the effectiveness of breast milk application versus sitz bath on episiotomy wound healing among post natal mothers in experimental group and comparison group.

·        To find out the association of episiotomy wound healing among post natal mothers with selected demographic variables in experimental group and comparison group

Hypothesis

Hypotheses will be tested at p< 0.05

H1- There will be significant difference in the episiotomy wound healing among post natal mothers in the experimental group (receiving breast milk application) and comparison group.

H2-There will be a significant difference in episiotomy wound healing among post natal mothers in the comparison group as compared to the experimental group

Methodology:

Research Approach: Quantitative Research .

Research Design: A Quasi experimental Research design.

Research Variables:

Dependent variables: Episiotomy wound healing

Independent variables: Breast milk application, Sitz bath

Target Population: Women admitted in selected Hospitals.

Sample size: Total 64 subject will be selected 32 in experiment group and 32 in comparison group by using Power Analysis.

 

Formula d= M1 – M2 / Spooled

 

Where : M1 = Mean of group 1

              M2 = Mean of group 2

             Spooled = pooled standard deviation for the two groups

Sample and Sampling techniques: Sample subjects will be post natal women , who will fulfil the inclusion criteria and the Sampling technique is convenience Sampling Technique .

Eligibility criteria:

Inclusion criteria: It includes:

·        Mothers who are within 24 to 48 hours post-delivery.

  • Mothers who don’t have any underlying medical conditions that could interfere with wound healing.
  • Mothers with an episiotomy wound (simple or intermediate).

Mothers who are willing to participate in the study

Exclusion criteria: It includes:

·       Mothers who have sustained a perineal tear.

·       Mothers who are diagnosed with any breast complications like mastitis and breast abscess.

·       Mothers who have known allergies or hypersensitivity reactions.

·       Mothers who are diagnosed with complications related to puerperium like puerperal sepsis, Post partum hemorrhage.

Method of data collection:

.Formal permission will be obtained from the community health centre after discussing the purposes and objectives of the study.

·   Participants meeting the inclusion and exclusion criteria will be selected.

·   A brief explanation about the purpose and objectives of the study will be provided, and informed consent will be taken after assuring the confidentiality of the study subject.

·   Participants will be randomly assigned to one of the two intervention groups: Group 1: Breast Milk Application, Group 2: Sitz Bath.

·   Group 1 (Breast Milk Application): Participants in this group will be instructed to express fresh breast milk and apply it to the episiotomy wound 2 times daily up to 7 postpartum days.

·   Group 2 (Sitz Bath): Participants in this group will be instructed to take sitz baths with warm water, possibly with an antiseptic solution, for 15-20 minutes, 2 times daily up to 7 postpartum days.

·   Appropriate water temperature (between 100°F to 105°F), duration, and frequency of the sitz bath should be ensured.

·   Wound healing assessment will be done using the standardized REEDA scale, checking for redness, edema, ecchymosis, discharge, and approximation of the wound edges during baseline data collection.

·   Follow-up data will be collected on Day 3, Day 5, and Day 7.

·   Day 3: Initial follow-up after intervention begins, mainly to monitor early effects and check for complications. If any signs of bacterial infection (Staphylococcus aureus, E. coli, Pseudomonas aeruginosa, and Streptococcus pyogenes) is observed during follow-up, the breast milk application will be immediately discontinued. The participant, will be referred to standard medical care as per clinical protocol.

·   Day 5: Midway follow-up to assess wound healing progress and any adverse effects.

·   Day 7: Final follow-up to assess the complete or near-complete wound healing and participant satisfaction

 

 
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