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CTRI Number  CTRI/2025/10/096006 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 13/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Other (Specify) [Kegal exercise and Prone position]  
Study Design  Other 
Public Title of Study   effectiveness of prone position on pain after delivery and kegel exercise on descrease in uterus size 
Scientific Title of Study   An experimental study to assess the effectiveness of prone position on afterpains and kegel exercise on involution of uterus among postnatal mother at selected hospital of Anand district 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ekta Patel 
Designation  Assistant Professor 
Affiliation  Institute of Nursing Sciences, Karamsad 
Address  Room no. 206, Institute of Nursing Sciences, Bhaikaka University, Gokal nagar, Karamsad

Anand
GUJARAT
388325
India 
Phone  8347433558  
Fax    
Email  ektapatel501@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ekta Patel 
Designation  Assistant Professor 
Affiliation  Institute of Nursing Sciences, Karamsad 
Address  Room no. 206, Institute of Nursing Sciences, Bhaikaka University, Gokal nagar, Karamsad

Anand
GUJARAT
388325
India 
Phone  8347433558  
Fax    
Email  ektapatel501@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anjali Makwana 
Designation  M. Sc. Nursing Student 
Affiliation  Institute of Nursing Sciences, Karamsad 
Address  classroom no. 207, Institute of Nursing Sciences, Bhaikaka University, Gokal nagar, Karamsad

Anand
GUJARAT
388325
India 
Phone  9664585943  
Fax    
Email  anjalimak247@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Shree Krishna Hospital 
Address  Shree Krishna Hospital, Bhaikaka University, Gokal Nagar, Karamsad, Anand, Gujarat- 388325 
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 Raithatha  Shree Krishna Hospital, Karamsad  Bhaikaka University, Gokal Nagar, Karamsad, Anand, Gujarat
Anand
GUJARAT 		 02692228224

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 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kegal exercise and Prone position  Participants of intervention group will receive prone position and kegel exercise. For prone positioning, postnatal mother will be instructed to lie in a prone position for 3-5 minutes with 30 min of interval for three times a day, after the prone position mother will be instructed for kegel exercise for which mother will be instructed to lie in supine position with knee bend and uplifting the hip and tightening pelvic muscles and than hip down for relaxing the pelvic floor muscles. This will be for 10 set of repetition, three times a day ,both intervention for 3 days. Control group will receive routine postnatal care. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1) Postnatal mother who belongs to the age group from 21 to 35 years
2) Postnatal mother who underwent with full term vaginal delivery one or more time.
3) Postnatal mother who delivered a single baby in this delivery.
4) Postnatal mother with or without episiotomy.
5) Postnatal mother who exclusively breastfeeding or not.
6) Postnatal mother who speaks and understand Gujarati or English. 
 
ExclusionCriteria 
Details  1)Postnatal mother underwent with cesarean section or instrumental delivery.
2) Postnatal mother with any postpartum abnormal condition related to reproductive system (post partum hemorrhage, puerperal sepsis, endometritis, perineal hematoma, pelvic organ prolapsed).
3)Postnatal mother associated with medical and surgical condition.
4) Postnatal mother with identified post partum psychological condition. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of prone position on afterpains among postnatal mother.  At baseline data and 3 days after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effectiveness of kegel exercise on involution of uterus among postnatal
mother. 		 At baseline data and 3 days after intervention 
To identify the association between the level of pain and degree of involution of uterus
with selected socio-demographic variable. 		 At baseline data 
 
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)   03/11/2025 
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="1"
Months="0"
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 aims to evaluate two non-pharmacological interventions to improve postpartum recovery. Using a true experimental pre-test post-test control group design, the research involves 60 postnatal mothers who had full-term normal vaginal deliveries, randomly assigned into experimental and control groups. The study assesses the impact of prone positioning on afterpains and Kegel exercises on uterine involution over three days. Data are collected through a standardized numerical pain rating scale and clinical measurement of fundal height. Ethical approval, informed consent, and confidentiality will be ensured. The study contributes to maternal healthcare by promoting cost-effective, simple, and non-invasive postpartum practices that can be integrated into routine nursing care. 
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