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CTRI Number  CTRI/2023/05/053133 [Registered on: 25/05/2023] Trial Registered Prospectively
Last Modified On: 19/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [VIDEO ASSISTED TEACHING ON of involutions of uterus and perineal pain ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluate the Effectiveness of abdominal muscle and video-assisted kegel exercise on involution of the uterus and perineal pain among Postnatal mothers ” 
Scientific Title of Study   “Randomized Controlled Trial to Evaluate the Effectiveness of abdominal muscle exercises and video-assisted kegel exercise on Involution of the uterus and perineal pain among Postnatal Mothers admitted to the Gynecology department of, IMS, BHU Varanasi.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajendra Kumar Jinjwaria 
Designation  Nursing Officer 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  Cardiothoracic ICU, Sir Sunderlal Hospital, Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI.
Cardiothoracic ICU, Sir Sunderlal Hospital, Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI.
Varanasi
UTTAR PRADESH
221005
India 
Phone  8871206912  
Fax    
Email  jinjwaria4137@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  UMA PANDEY 
Designation  Professor 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  room No 3, 5th floor, Department of Gynaecology, Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI.
room No 3, 5th floor, Department of Gynaecology, Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI.
Varanasi
UTTAR PRADESH
221005
India 
Phone  8871206912  
Fax    
Email  kapuriyasaroj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rajendra Kumar Jinjwaria 
Designation  Nursing Officer 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  Cardiothoracic ICU, Sir Sunderlal Hospital, Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI.
Cardiothoracic ICU, Sir Sunderlal Hospital, Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI.
Varanasi
UTTAR PRADESH
221005
India 
Phone  8871206912  
Fax    
Email  jinjwaria4137@gmail.com  
 
Source of Monetary or Material Support  
room no 3, 5th floor, mch wing gynaecology department, ims, bhu 
 
Primary Sponsor  
Name  Rajendra Kumar Jinjwaria 
Address  2nd Floor, department of CTVS, IMS, BHU. 
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 
Rajendra  department of gynology, ims, bhu  room no. 101, gynology department, IMS, BHU(5th floor)
Varanasi
UTTAR PRADESH 		 8871206912

jinjwaria4137@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Banaras Hindu University Institute of Medical Sciences Varanasi India- 221005  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  HOSPITAL ROUTINE ACTIVITY  3 time a day for 15 minutes for 2 weeks 
Intervention  VIDEO ASSISTED TEACHING ON INVOULATION OF UTERUS AND PERINEAL PAIN  3 time a day for 15 minutes for 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Postnatal mothers with normal vaginal delivery.
2. Postnatal mothers who can understand Hindi and English.
3. Postnatal mothers who are willing and available at the time of data collection.
 
 
ExclusionCriteria 
Details  1. Postnatal mothers who is critically ill.
2. The mothers who have undergone forceps and ventouse extraction delivery.
3. Postnatal mother with operative deliveries.
4. Women less than 18 years and more than 40 years
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess the pre-test and post-test scores of involutions of the uterus and perineal pain among postnatal mothers in the experimental and control group.
2. To determine the effectiveness of video-assisted Kegel exercise and abdominal muscle exercises on the involution of the uterus and perineal pain among postnatal mothers in the experimental group. 		 2 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
• To find an association between post-test score of involutions of uterus and perineal pain among postnatal mothers with their selected demographic variables.  PRE TEST ON 1ST DAY 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/05/2023 
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="1"
Days="1" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 18-01-2024 and end date provided 18-01-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

·       To assess the pre-test and post-test scores of involutions of uterus and perineal pain among postnatal mothers in experimental and control group.

·       To determine the effectiveness of video assisted Kegel exercise and abdominal muscle exercises on involution of uterus and perineal pain among postnatal mothers in experimental group.

·       To compare the effectiveness of video assisted Kegel exercise and abdominal muscle exercises on involution of uterus and perineal pain among postnatal mothers in experimental and control group.

·       To find an association between post-test score of involutions of uterus and perineal pain among postnatal mothers with their selected demographic variables.

 
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