FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/095138 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 19/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [alternating application of cold and hot compress on painful breast engorgement]  
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   effect of Alternating Application of Cold and Hot Compress on painful breast engorgement among postnatal mothers : Non-randomized control trial 
Scientific Title of Study   The effect of alternating application of cold and hot compress on painful breast engorgement among postnatal mothers in postnatal wards at tertiary care hospital 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kumkum  
Designation  student 
Affiliation  King Georges Medical University KGMU College of Nursing 
Address  King Georges Medical University, Chowk, Lucknow
King Georges Medical University, Chowk, Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  6393197674  
Fax    
Email  kumkumsingh731854@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs. Suman lata 
Designation  Assistant Professor 
Affiliation  King Georges Medical University 
Address  King George’s Medical University Shah Mina Road, Chowk, Lucknow Uttar Pradesh, India – 226003
King Georges Medical University KGMU College of nursing
Lucknow
UTTAR PRADESH
226003
India 
Phone  9729764723  
Fax    
Email  Sumanlata@kgmcindia.edu   
 
Details of Contact Person
Public Query  
Name  Kumkum 
Designation  student 
Affiliation  King Georges Medical University 
Address  King George’s Medical University Shah Mina Road, Chowk, Lucknow Uttar Pradesh, India – 226003
King George’s Medical University Shah Mina Road, Chowk, Lucknow Uttar Pradesh, India – 226003
Lucknow
UTTAR PRADESH
226003
India 
Phone  6393197674  
Fax    
Email  kumkumsingh731854@gmail.com   
 
Source of Monetary or Material Support  
King George’s Medical University Shah Mina Road, Chowk, Lucknow Uttar Pradesh, India – 226003 Queen Marys hospital Obstetrics and gynecology department Postnatal wards  
 
Primary Sponsor  
Name  Kumkum 
Address  King Georges medical university 226003 Chowk Lucknow U.P. 
Type of Sponsor  Other [SELF ] 
 
Details of Secondary Sponsor  
Name  Address 
Suman lata tanima verma priti mishra rozee anees   King Georges medical university 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kumkum   King george medical university Quin Marys hospital  King George’s Medical University Shah Mina Road, Chowk, Lucknow Uttar Pradesh, India – 226003 Queen Marys hospital Obstetrics and gynecology department, Postnatal wards
Lucknow
UTTAR PRADESH 		 6393197674

kumkumsingh731854@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
king george medical university UP Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O912||Nonpurulent mastitis associated with pregnancy, the puerperium and lactation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  alternating application of cold and hot compress on painful breast engorgement on postnatal mothers   A cold gel pack (10°C to 18°C, as measured by a lotion thermometer) was placed over the engorged breast. The pack was covered with a clean, dry towel and placed directly inside the mother’s bra. This intervention lasted for 15-20 minutes, and it was replaced every one to two minutes to prevent ischemia. Thirty minutes after the cold gel pack was taken off, a hot compress (43°C - 46°C, as measured by a lotion thermometer) was placed over the engorged breast. The hot compress was covered with a clean, dry towel as well and was replaced every one to two minutes. This intervention lasted for 15-20 minutes. 
Comparator Agent  usual care   usual care  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Postnatal mothers who are admitted to the postnatal ward Queen Mary Hospital Lucknow
2.Postnatal mothers whose breast engorgement is more than 3 in six-point scale
3.Postnatal mothers whose breasts are engorged and stayed in hospital for 1 to 5 days
 
 
ExclusionCriteria 
Details  • Postnatal mothers who are not willing to participate.
• Postnatal mothers who are sick or have a history of breast surgery.
• Postnatal mothers with cognitive impairment
• Postnatal mothers with psychiatric illness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
the outcome of the study will be to reduce painful engorgement   after 3 days 
 
Secondary Outcome  
Outcome  TimePoints 
the outcome of the study will be to reduce painful engorgement   outcome will be measured at 5 days  
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
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   Phase 3 
Date of First Enrollment (India)   15/10/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Problem: Breast engorgement is a common, painful condition affecting many breastfeeding mothers in the first few weeks after childbirth. It can lead to discomfort, mastitis, and premature cessation of breastfeeding.

Purpose of the Study: To determine the effectiveness of alternately applying cold and hot compresses to reduce painful breast engorgement in postnatal mothers.

Background:

Breast engorgement occurs when breasts become overly full, hard, and painful due to lymphatic and vascular congestion and increased milk production.

It’s a significant reason for mothers to stop breastfeeding, affecting 72%-85% of mothers, typically 3-6 days postpartum.

Non-pharmacological methods like hot and cold compresses are increasingly popular due to concerns about medication side effects, ease of use, convenience, and lower cost.

Hot compresses are thought to trigger milk ejection and reduce edema, while cold compresses cause vasoconstriction, reducing blood flow, pain, and swelling.

Objectives:

To assess the pre-intervention score of painful breast engorgement.

To determine the effectiveness of the alternating application of cold and hot compresses in reducing painful breast engorgement.

To find an association between the pre-intervention engorgement score and selected demographic variables.

Hypothesis: There will be a significant difference in painful breast engorgement levels between pre-test and post-test after the alternating application of cold and hot compresses.

Methodology:

Research Approach & Design: Quantitative research using a Quasi-experimental design (non-randomized control design).

Setting: Department of Obstetrics and Gynecology, King George’s Medical University, Lucknow (specifically the postnatal ward of Queen Mary Hospital).

Population: Postnatal mothers experiencing painful breast engorgement (score > 3 on a six-point scale) within 1-5 days postpartum, who are conscious and willing to participate.

Sampling: Purposive sampling technique.

Sample Size: A minimum of 64 mothers per group (experimental and control), or 71 per group considering 10% attrition.

Variables:

Independent: Alternating application of cold and hot compress.

Dependent: Level of painful breast engorgement.

Tools:

Demographic variables form.

Bristol Breastfeeding Assessment Tool.

LATCH questionnaire.

Visual Analogue Pain Scale (VAS).

Six-Point Breast Engorgement Scale (SPES) for assessing engorgement level (1-2 mild, 3-5 moderate, 6-9 severe).

Expected Outcome (Implied): The study anticipates that the alternating application of cold and hot compresses will significantly reduce painful breast engorgement, thereby improving breastfeeding outcomes for postnatal mothers. This will provide evidence-based strategies for healthcare providers to better support breastfeeding mothers and contribute to the existing knowledge on effective engorgement management.

 

 
Close