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CTRI Number  CTRI/2024/10/074837 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 05/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness of using video lessons to teach sexual health to teenage girls. 
Scientific Title of Study   Effectiveness of Video Assisted Teaching Tool on Sexual Health among Adolescent Girls In Selected Schools 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PORKODI M 
Designation  PROFESSOR 
Affiliation  VYDEHI INSTITUTE OF NURSING SCIENCES AND RESEARCH CENTRE 
Address  HOD, DEPARTMENT OF PSYCHIATRIC NURSING, VYDEHI INSTITUTE OF NURSING SCIENCES AND RESEARCH CENTRE
#82 EPIP AREA, WHITEFIELD,BENGALURU
Bangalore
KARNATAKA
560066
India 
Phone  9448386332  
Fax    
Email  porkodimichael@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  DR SUBBULAKSHMI S 
Designation  VICE PRINCIPAL 
Affiliation  CHETTIAD COLLEGE OF NURSING 
Address  PROFESSOR, DEPARTMENT OF PAEDIATRIC NURSING, CHETTIAD COLLEGE OF NURSING CHETTINAD ACADEMY OF RESEARCH AND EDUCATION (CARE) RAJIV GANDHI SALAI KELAMBAKKAM

Chennai
TAMIL NADU
603103
India 
Phone  9944592175  
Fax    
Email  kbsubbulakshmi@gmail.com  
 
Details of Contact Person
Public Query  
Name  PORKODI M 
Designation  PROFESSOR 
Affiliation  VYDEHI INSTITUTE OF NURSING SCIENCES AND RESEARCH CENTRE 
Address  HOD, DEPARTMENT OF PSYCHIATRIC NURSING, VYDEHI INSTITUTE OF NURSING SCIENCES AND RESEARCH CENTRE
VYDEHI INSTITUTE OF NURSING SCIENCES AND RESEARCH CENTRE #82 EPIP AREA, WHITEFIELS, BENGALURU
Bangalore
KARNATAKA
560066
India 
Phone  9448386332  
Fax    
Email  porkodimichael@yahoo.in  
 
Source of Monetary or Material Support  
SELF 
 
Primary Sponsor  
Name  PORKODI M 
Address  VYDEHI INSTITUTE OF NURSING SCIENCES AND RESEARCH CENTRE #82 EPIP AREA, WHITEFIELD, BENGALURU 
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 
PORKODI M  SELECTED SCHOOLS IN BENGALURU  BENGALURU
Bangalore
KARNATAKA 		 9448386332

porkodimichael@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE FOR STUDENT RESEARCH (CARE IHEC-I)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ICD 10 - F66 AND F64  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NO INTERVENTION RELATED TO THE TOPIC  NO INTERVENTION WILL BE GIVEN BY THE INVESTIGATOR TO THE CONTROL GROUP. ONLY EXISTING KNOWLEDGE WILL BE ASSESSED.  
Intervention  VIDEO ASSISTED TEACHING TOOL   VIDEO LESSONS WILL BE INCLUDING ALL THE ASPECTS OF SEXUAL HEALTH SUCH AS ANATOMY AND PHYSIOLOGY OF REPRODUCTIVE SYSTEM, MENSTRUATION, MENSTRUAL HYGIENE, SEXUAL ORIENTATION, GENDER IDENTITIES AND ITS ROLE, CONTRACEPTION AND PREVENTION OF SEXUALLY TRANSMITTED DISEASES AMONG ADOLESCENT GIRLS. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  19.00 Year(s)
Gender  Female 
Details  The study includes all the students
1. between the age of 15 and 19 years
2. who have attained menarche
3. from urban and rural background
4. whose parents give their consent in writing
 
 
ExclusionCriteria 
Details  The study excludes students who are:
1. not available at the time of study
2. not cooperative for the study
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
IMPROVEMENT IN THE KNOWLEDGE LEVEL, DEVELOPING A POSITIVE ATTITUDE AND BODY IMAGE REGARDING SEXUAL HEALTH AMONG ADOLESCENT GIRLS.   SOON AFTER THE INTERVENTION. 
 
Secondary Outcome  
Outcome  TimePoints 
Helps to build a strong foundation for lifelong sexual health.
When adolescent girls are educated & aware of sexual wellness, they make better reproductive decisions. This means fewer teenage pregnancies, child mortality, or sexually transmitted infections.
Establishing & Maintaining Positive & Responsible Relationships
 		 Long term more than 2 years 
 
Target Sample Size   Total Sample Size="261"
Sample Size from India="261" 
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)   16/10/2024 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

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

  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 - Proposals should be directed to [porkodimichael@yahoo.in].

  6. For how long will this data be available start date provided 24-09-2024 and end date provided 24-03-2025?
    Response - Immediately following publication. No end date.

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

Education on sexual health encompasses a range of relationships, not only sexual relationships. Children are aware of and recognize these relationships long before they act on their sexuality and therefore need the skills to understand their bodies, relationships and feelings from an early age.

 
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