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CTRI Number  CTRI/2025/11/097037 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [effect of footbath on postpartum fatigue and sleep pattern]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Footbath therapy for reducing fatigue and improving sleep pattern in post-cesarean mothers 
Scientific Title of Study   A true experimental study to assess the effectiveness of footbath on post partum fatigue and sleep pattern on postnatal caesarean mothers at selected hospital of Anand district,Gujarat 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vandana Shrimali 
Designation  Associate Professor 
Affiliation  Institute of Nursing Sciences,Shri G H Patel School of Nursing,Bhaikaka University,Karamsad 
Address  Room No.208, First Floor,Department of Obstetric and Gynaecological Nursing,Institute of Nursing Sciences,Shri G H Patel School of Nursing,Bhaikaka University,Karamsad

Anand
GUJARAT
388325
India 
Phone  9925064426  
Fax    
Email  vsdeep227@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vandana Shrimali 
Designation  Associate Professor 
Affiliation  Institute of Nursing Sciences,Shri G H Patel School of Nursing,Bhaikaka University,Karamsad 
Address  Room No.208, First Floor,Department of Obstetric and Gynaecological Nursing,Institute of Nursing Sciences,Shri G H Patel School of Nursing,Bhaikaka University,Karamsad

Anand
GUJARAT
388325
India 
Phone  9925064426  
Fax    
Email  vsdeep227@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nikita Thakor 
Designation  M.Sc.Nursing Student 
Affiliation  Institute of Nursing Sciences,Karamsad 
Address  Room No.206, First Floor,Department of Obstetric and Gynaecological Nursing,Institute of Nursing Sciences,Shri G H Patel School of Nursing,Bhaikaka University,Karamsad

Anand
GUJARAT
388325
India 
Phone  7990298314  
Fax    
Email  thakorsoni123@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Shree Krishna Hospital 
Address  Shree Krishna Hospital,Gokal Nagar,Bhaikaka University,Karamsad 
Type of Sponsor  Private hospital/clinic 
 
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 Nitin S Raithatha  Shree Krishna Hospital  Room No 161 Department of Obstetrics and Gynaecology Gokal Nagar Bhaikaka University Karamsad 388325
Anand
GUJARAT 		 9825197277

nitinsr@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaikaka University,Karamsad,Anand,Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Postnatal caesarean mothers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Footbath Postpartum Fatigue  Written permission taken from hospital site authority.The intervention will be started on the 2nd postnatal day following caesarean delivery. Prior to implementing the intervention, participants will be randomly assigned to either the experimental group or the control group using the GIGA calculator for simple randomization. Part I – Effect of Warm Footbath Therapy on Postpartum Fatigue Pre-test (Day 2): Postpartum fatigue will be assessed using the standardized Fatigue Severity Scale (FSS). Intervention for Experimental Group: Participants in the experimental group will receive warm footbath therapy according to a standardized protocol (maintaining appropriate temperature, duration, and frequency). This intervention will be given once daily for the specified number of days to assess its effectiveness on fatigue reduction. Control Group: Participants in the control group will receive routine hospital postnatal care without the footbath intervention. Post-test: After completion of the intervention period, postpartum fatigue will again be assessed using the FSS to determine the difference between pre- and post-test scores. 
Intervention  Footbath Sleep Pattern  Written permission taken from hospital site authority.The intervention will be started on the 2nd postnatal day following caesarean delivery. Prior to implementing the intervention, participants will be randomly assigned to either the experimental group or the control group using the GIGA calculator for simple randomization. Part II – Effect of Warm Footbath Therapy on Sleep Pattern Pre-test (Day 2): Sleep quality will be assessed using the Modified Sleep Quality Scale (SQS). Intervention for Experimental Group: The same warm footbath therapy procedure will be used as in the fatigue study, following the same standardized protocol. This therapy will be administered once daily for the same duration, but the outcome measure here will be sleep quality improvement. Control Group: Participants in the control group will receive routine postnatal care only, without the warm footbath therapy. Post-test: After completion of the intervention period, post-test sleep quality will be assessed using the Sleep Quality Scale to evaluate the effect of the intervention on sleep quality. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1)Postnatal mother who have undergone for caesarean delivery.
2)Postnatal mothers Age between 18 to 40 years.
3)Postnatal mothers who are within 2 -4 days postpartum.
4)Postnatal mothers who experiencing fatigue and sleep disturbances.
5)Postnatal mothers who can read and write English, Gujrati and Hindi.

 
 
ExclusionCriteria 
Details  1)Postnatal mothers with foot infections, wounds, or skin conditions that prevent footbath therapy.
2)Postnatal mothers with any major medical or psychiatric illness .
3)Postnatal mothers taking sedatives or sleep medications regularly.
4)Postnatal mothers who are not cooperative or unable to communicate effectively.
5)Postnatal mothers who are discharged before the completion of the intervention
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of footbath on level of postpartum fatigue among postnatal caesarean mothers.  Baseline pre-test measurement of postpartum fatigue will be taken before administration of the first footbath intervention (within 24 hours after cesarean delivery). Post-test measurements will be taken immediately after the final footbath session on Day 3 postpartum. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effectiveness of footbath on level of postpartum fatigue among postnatal caesarean mothers of experimental group and control group.
To identify the association between sociodemographic variable and postpartum fatigue among postnatal caesarean mothers.
To assess the effectiveness of footbath on improving sleep quality among postnatal caesarean mothers.
 		  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/11/2025 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

The present study will aim to evaluate the effectiveness of warm footbath therapy on postpartum fatigue and sleep patterns among postnatal caesarean mothers. Participants will be selected using simple random sampling and divided into experimental and control groups. The experimental group will receive a warm footbath intervention, where feet will be immersed in warm water (37°C–40°C) for 20 minutes daily for three consecutive days, while the control group will receive routine postnatal care. Data will be collected using standardized tools — the Fatigue Severity Scale (FSS) to assess fatigue levels and the Sleep Quality Scale (SQS) to evaluate sleep patterns — both before and after the intervention. The study will determine whether the footbath therapy effectively reduces postpartum fatigue and improves sleep quality among caesarean mothers. It is expected that post-test scores of the experimental group will show significant improvement, demonstrating that footbath therapy is a simple, safe, and cost-effective complementary nursing intervention that can enhance maternal recovery, relaxation, and overall well-being during the postnatal period.

 

 

 

 

 

 

 
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