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CTRI Number  CTRI/2025/09/094571 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Information, Education and Communication (IEC) package]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Effect of Information, Education and Communication (IEC) package 
Scientific Title of Study   A randomized controlled trial to assess the effectiveness of Information, Education and Communication (IEC) package in enhancing knowledge regarding sexual and reproductive health among undergraduate girls in selected colleges of Jalandhar, Punjab 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muskan 
Designation  Msc(N) Student 
Affiliation  MHR DAV Institute of nursing, Jalandhar 
Address  Mahatma Hans Raj DAV Institute of Nursing Gulab Devi Road, Arya Nagar Jalandhar - 144008 Punjab, India
Mahatma Hans Raj DAV Institute of Nursing Gulab Devi Road, Arya Nagar Jalandhar - 144008 Punjab, India
Jalandhar
PUNJAB
144002
India 
Phone  6284506708  
Fax  01812259266  
Email  muskanbangotra06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sharad Chand Gupta 
Designation  Associate Professor 
Affiliation  MHR DAV Institute of nursing, Jalandhar 
Address  Mahatma Hans Raj DAV Institute of Nursing Gulab Devi Road, Arya Nagar Jalandhar - 144008 Punjab, India
Mahatma Hans Raj DAV Institute of Nursing Gulab Devi Road, Arya Nagar Jalandhar - 144008 Punjab, India
Jalandhar
PUNJAB
144008
India 
Phone  8427374284  
Fax  01812259266  
Email  drsharadgupta11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jophy Elezabeth George 
Designation  Professor 
Affiliation  MHR DAV Institute of nursing, Jalandhar 
Address  MHR DAV Institute of nursing, gulab devi road, arya nagar, Jalandhar

Jalandhar
PUNJAB
144008
India 
Phone  8827375337  
Fax  01812259266  
Email  jophyegeorge5@gmail.com  
 
Source of Monetary or Material Support  
MHR DAV Institute of nursing, Jalandhar 
 
Primary Sponsor  
Name  Muskan 
Address  Mahatma Hans Raj DAV Institute of Nursing Gulab Devi Road, Arya Nagar Jalandhar - 144008 Punjab, India 
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 
Muskan  Hans Raj Mahila Maha Vidyalaya  Mahatma Hans Raj Marg, Grand Trunk Rd, Jalandhar, Punjab 144008
Jalandhar
PUNJAB 
6284506708
2203453
info@hrmmv.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MHR DAV Institute of Nursing, Jalandhar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy undergraduate girls 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Information, Education and Communication (IEC) package  The Information, Education, and Communication (IEC) package will be divided into 4 interactive sessions, which will be administered each in 4 consecutive days. Session I- Unwed Mothers Session II- Contraception Session III- STD’s: HIV, HPV, syphilis, gonorrhoea & its prevention Session IV- Healthy relationships  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Month(s)
Age To  22.00 Year(s)
Gender  Female 
Details  The undergraduate girls that are willing and accessible during the time of data collection. 
 
ExclusionCriteria 
Details  The undergraduate girls who were not present during the time of data collection. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To plan and administer Information, Education and Communication (IEC) package  4 days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of Information, Education and Communication (IEC) package.   1 day 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 4 
Date of First Enrollment (India)   02/03/2026 
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="0"
Days="6" 
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 - NO
Brief Summary  

Good sexual and reproductive health is important for women’s general health and wellbeing. It is central to their ability to make choices and decisions about their lives, including when, or whether, to consider having children. Sexual and reproductive health is not only about physical wellbeing, it includes the right to healthy and respectful relationships, health services that are inclusive, safe and appropriate, access to accurate information, effective and affordable methods of contraception. If the knowledge is lacking among the young girls and the girls who are undergraduates, it will leads to sexually transmitted diseases and reproductive tract infections. Sexually transmitted diseases (STDs) are caused by sexually transmitted infections (STIs). A randomized controlled trial will be conducted to see the effectiveness of Information, Education, and Communication (IEC) package in enhancing knowledge regarding sexual and reproductive health among undergraduate girls in selected colleges of Jalandhar, Punjab. The IEC package includes demonstrations, lectures, case-based discussion, visual aids and printed materials. Probability sampling technique (cluster randomization) will be used to collect sample  from selected colleges of Jalandhar, Punjab. Data analysis will be performed by descriptive and inferential statistics.

 
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