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CTRI Number  CTRI/2025/09/094781 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 13/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Effect of relaxation technique on pain and sleep in mothers after caesarean delivery 
Scientific Title of Study   A study to assess the effectiveness of Jacobson’s Progressive Muscle Relaxation Technique on pain and sleep quality among post-cesarean section mothers at selected hospitals of Punjab. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Amanpreet Kaur 
Designation  Assistant Professor 
Affiliation  Chitkara University 
Address  Chitkara School of Health Sciences, Chitkara University Rajpura Punjab.

Patiala
PUNJAB
140401
India 
Phone  8054945644  
Fax    
Email  kaur.amanpreet@chitkara.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Gurjot Kaur 
Designation  Post graduation student 
Affiliation  Chitkara University 
Address  Chitkara School of Health Sciences, Chitkara University Rajpura Punjab.

Patiala
PUNJAB
140401
India 
Phone  07879000094  
Fax    
Email  gurjot2502.don24@chitkara.edu.in  
 
Details of Contact Person
Public Query  
Name  Gurjot Kaur 
Designation  Post graduation student 
Affiliation  Chitkara University 
Address  Chitkara School of Health Sciences, Chitkara University Rajpura Punjab.

Patiala
PUNJAB
140401
India 
Phone  07879000094  
Fax    
Email  gurjot2502.don24@chitkara.edu.in  
 
Source of Monetary or Material Support  
Chitkara school of health sciences, department of nursing, Chitkara University Rajpura Punjab, India. pin code: 140401 
 
Primary Sponsor  
Name  Gurjot Kaur 
Address  Chitkara School of Health Sciences, Chitkara University Rajpura Punjab , India, Pincode: 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 Daljeet Kaur  Mata Kaushlya Hospital, 6-phase govt. Hospital  Room no. 201 second floor maternal and child health building, district Patiala, India and SMO room maternal and child health building district Mohali, India
Patiala
PUNJAB 		 01752222481

prachigupta20001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONALHUMAN ETHICAL 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: O900||Disruption of cesarean delivery wound,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Jacobson progressive muscle relaxation technique.  Start: Prepare Environment • Quiet, comfortable space • Mother seated/lying comfortably Step 1: Deep Breathing (2 min) • Inhale for 4 sec, hold for 2 sec, exhale for 6 sec * Repeat for relaxation Step 2: Muscle Relaxation (10 min) Systematic contraction (5 sec) and relaxation (10 sec) repeat each exercise 3 times Target muscle groups: 1.Forehead: Raise your eyebrows as high as you can creating tension in your forehead. – Relax 2. Eyes: close tightly – Relax 3. Jaw: clench your teeth tightly – Relax 4. Neck: Gently press chin to chest – Relax 5. Shoulders: Shrug upward – Relax 6. Tighten your right arm muscles from shoulder to wrist – Relax 7. Tighten your left arm muscles from shoulder to wrist – Relax 8. Hands: Clench fists tightly – Relax 9. Hips & Buttocks: Squeeze your buttocks tightly – Relax 10. Tighten your right thigh and lower leg muscles – Relax. 11. Tighten your left thigh and lower leg muscles – Relax. 12. Feet: Curl your toes downward – Relax Stretch toes upward – Relax. Step 3: Full-Body Relaxation (3 min) • Focus on the relaxed state of each muscle group • Practice deep breathing for overall relaxation  
Comparator Agent  Standardized care   Mothers will receive standardized post-cesarean routine care provided at the study hospitals — including assessment and management of pain with routine analgesics as per hospital protocol, wound care, breastfeeding support, ambulation guidance, and general sleep hygiene counselling. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Mothers willing to participate in the study and provide informed consent.
2. Mothers available at the time of data collection. 
 
ExclusionCriteria 
Details  1.Mothers having any postnatal complications with systemic illness.
2.Mothers with normal vaginal delivery postnatal mothers.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
JPMR technique will effective to reduce pain and improve sleep quality.  6TH 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   Phase 1 
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

Cesarean section is one of the most commonly performed surgical procedures worldwide to ensure maternal and fetal well-being. However, post cesarean mothers often experience acute postoperative pain and impaired sleep quality which can negatively impact their physical recovery emotional well-being and ability to care for their newborns. Effective pain management and improved sleep quality are crucial for enhancing maternal postpartum recovery and overall health outcomes

Jacobson Progressive Muscle Relaxation has been found effective in managing pain and anxiety among various patient populations including postoperative mothers. The technique works by reducing muscle tension enhancing circulation and promoting parasympathetic nervous system activity which can alleviate postoperative discomfort and improve sleep quality. Given its simplicity cost effectiveness and non invasive nature Jacobson Progressive Muscle Relaxation can be an essential adjunct to standard post cesarean care

Review of Literature

Devmurari and Nagrale 2018 conducted a quasi experimental study to evaluate the effectiveness of Jacobson Progressive Muscle Relaxation in managing pain among post cesarean women. The study included thirty four participants with the experimental group practicing Jacobson Progressive Muscle Relaxation for five consecutive days. Pain levels were assessed using the Visual Analog Scale. Results indicated a significant reduction in pain levels in the experimental group compared to the control group demonstrating the effectiveness of Jacobson Progressive Muscle Relaxation as a non pharmacological pain management technique

Ismail and Elgzar 2018 conducted a randomized controlled trial to assess the impact of progressive muscle relaxation on post cesarean pain sleep quality and physical activity limitations. The study included sixty participants divided into intervention and control groups. The intervention group practiced Jacobson Progressive Muscle Relaxation daily for one week. Findings revealed a statistically significant improvement in sleep quality reduced pain perception and enhanced physical activity tolerance among the intervention group. The study concluded that Jacobson Progressive Muscle Relaxation is an effective adjunct therapy for postoperative recovery

Ismail and Elgzar 2021 examined the effects of Jacobson Progressive Muscle Relaxation on postoperative pain activity tolerance and sleep quality in eighty post cesarean patients. Participants were assigned to either an experimental or control group with the experimental group practicing Jacobson Progressive Muscle Relaxation for thirty minutes three times a day. The REEDA scale and Pittsburgh Sleep Quality Index were used for assessment. Results demonstrated significant reductions in pain scores and improvements in sleep quality among the intervention group supporting Jacobson Progressive Muscle Relaxation as a beneficial technique in postoperative care

Problem Statement

A study to assess the effectiveness of Jacobson Progressive Muscle Relaxation Technique on pain and sleep quality among post cesarean section mothers at selected hospitals of Punjab

Aim of the Study

The aim of this study is to assess the effectiveness of Jacobson Progressive Muscle Relaxation technique on pain and sleep quality among post cesarean section mothers

Justification for Study

Post cesarean section mothers commonly experience significant pain and sleep disturbances due to surgical trauma hormonal changes and postpartum stress. Uncontrolled pain can lead to delayed recovery increased stress poor maternal infant bonding and higher healthcare costs due to prolonged hospital stays. Additionally sleep deprivation is linked to postpartum depression impaired wound healing and reduced lactation efficiency affecting both maternal and neonatal outcomes

Traditional pain management relies on pharmacological interventions such as opioids and nonsteroidal anti inflammatory drugs. However these medications carry risks of side effects including nausea dizziness sedation and potential dependency limiting their long term use. Non pharmacological interventions particularly relaxation techniques have gained attention as complementary approaches to pain and stress management in postpartum care

Objectives

1 To assess and compare the effect of Jacobson Progressive Muscle Relaxation technique on level of pain among post cesarean section mothers in experimental and comparison groups
2 To assess and compare the effect of Jacobson Progressive Muscle Relaxation technique on sleep quality among post cesarean section mothers in experimental and comparison groups
3 To find out the association of post test pain level among post cesarean section mothers with selected socio demographic variables in experimental and comparison groups
4 To find out the association of post test sleep quality among post cesarean section mothers with selected socio demographic variables in experimental and comparison groups

Hypotheses

H1a There will be a significant difference in mean pre and post test score of pain among post cesarean mothers in the experimental group
H1b There will be a significant difference in mean post test score of pain among post cesarean mothers in experimental and comparison groups
H2a There will be a significant difference between mean pre and post test score of sleep quality among post cesarean mothers in experimental group
H2b There will be a significant difference between mean post test score of sleep quality among post cesarean mothers in experimental and comparison groups
H3a There will be a significant association of post test level of pain among post cesarean mothers in experimental group with their selected socio demographic variables
H3b There will be a significant association of post test level of pain among post cesarean mothers in comparison group with their selected socio demographic variables
H4a There will be a significant association of post test sleep quality among post cesarean mothers in experimental group with their selected socio demographic variables
H4b There will be a significant association of post test sleep quality among post cesarean mothers in comparison group with their selected socio demographic variables

Methodology

Research Approach Quantitative research approach
Research Design Quasi experimental pre test post test design with comparison group
Research Setting Selected hospitals of Punjab including Mata Kaushalya Hospital AP Jan Hospital and Six Phase Government Hospital Mohali
Population Post cesarean section mothers admitted in the postnatal ward
Sample Size Calculated using Cohen formula Effect size 0.5 significance level 0.05 power 80 Sample size per group 32 Total sample size 64
Data Analysis Descriptive and inferential statistics using SPSS software

Risk and Benefits

There is minimal risk from participation in this study. The potential benefits include reduced pain and improved sleep quality among post cesarean mothers

Expected Outcomes

It is anticipated that Jacobson Progressive Muscle Relaxation will significantly reduce pain and improve sleep quality among post cesarean section mothers in the experimental group compared to the comparison group. Findings will help in incorporating Jacobson Progressive Muscle Relaxation as a standard non pharmacological intervention in postnatal care

Ethical Considerations

Approval will be obtained from the institutional ethical committee. Informed consent will be taken from all participants. Confidentiality and anonymity of data will be maintained

Data Collection Procedure

Permission to collect the data will be obtained from Mata Kaushalya Hospital AP Jan Hospital Rajpura and Six Phase Government Hospital Mohali. A brief about the study will be explained to the patients and written informed consent will be obtained. The intervention Jacobson Progressive Muscle Relaxation technique will be given for five days. Post test will be conducted on the sixth day


 
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