| 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
|
|
|
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
|
|
|
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. |