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CTRI Number  CTRI/2021/12/038482 [Registered on: 07/12/2021] Trial Registered Prospectively
Last Modified On: 03/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral
Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A trial to study the effect of video assissted teaching about diet and exercise on prevention of constipation among women after delivery. 
Scientific Title of Study   Effectiveness of video assisted teaching on prevention of constipation among postpartum women admitted in postnatal ward at a tertiary care hospital - A Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
JIP/CON/NRMC/M.Sc./2020/OBG/5 dated 20 May 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tamil Selvi C 
Designation  M Sc Nursing Student 
Affiliation  JIPMER 
Address  MSc Nursing II year-obstetrics and Gyanaecological Nursing college of Nursing JIPMER Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9176068821  
Fax    
Email  jothipc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vahitha S 
Designation  Lecturer 
Affiliation  JIPMER 
Address  Room no 202 Department- Obstetrics and gynaecological nursing College of Nursing JIPMER Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9840924805  
Fax    
Email  vahiarun@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vahitha S 
Designation  Lecturer 
Affiliation  JIPMER 
Address  Room no 202 Department- Obstetrics and gynaecological Nursing College of Nursing JIPMER Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9840924805  
Fax    
Email  vahiarun@gmail.com  
 
Source of Monetary or Material Support  
JIPMER 
 
Primary Sponsor  
Name  Intramural Fund JIPMER 
Address  Intramural Fund Committee JIPMER Puducherry 
Type of Sponsor  Research institution and hospital 
 
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 
Vahitha S  JIPMER  Obstetrics and gynaecology OPD
Pondicherry
PONDICHERRY 		 9840924805

vahiarun@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee for nursing courses, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  routine care   Routine care is the pamphlet regarding the postnatal care issued in the hospital routinely on discharge of all postnatal women.  
Intervention  Video assisted teaching  video assisted teaching regarding diet and exercise for the prevention of constipation will be given at the time of recruitment and on the postnatal day 1. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Adult females with uncomplicated pregnancy of 37 weeks of gestation and above and no history of GI problems or prior surgery.
Uncomplicated pregnancy means absence of high risk factors.
 
 
ExclusionCriteria 
Details  women with medical or obstetrical comorbidities and those with third degree perineal injury. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
status of constipation  at the end of 2 weeks of post partum period 
 
Secondary Outcome  
Outcome  TimePoints 
association between socio demographic variables obstetric variables and status of constipation  at the end of 2nd week of postpartum period. 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/12/2021 
Date of Study Completion (India) 02/02/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Trial completed. not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response (Others) -  Deidentified patient data will be shared during publication of the study.

  5. By what mechanism will data be made available?
    Response (Others) -  Deidentified patient data like sociodemographic, obstetric variables and the outcome details will be shared during publication of the study.

  6. For how long will this data be available start date provided 31-12-2022 and end date provided 31-12-2025?
    Response (Others) -  data will be preserved for three years after publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary    This study is a randomized controlled trial to assess the effectiveness of video assisted teaching regarding diet and exercise on the prevention of constipation among postpartum women admitted in a tertiry care hospital puducherry. the primary outcome is status of constipation at the end of 2 weeks of postpartum period. the secondary outcome is to find out the association between sociodemographic variables, obstetric variables and status of constipation. 
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