| CTRI Number |
CTRI/2025/09/094600 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
To study effectiveness of standard health education ,peerled and mobile health intervention on improving menstrual hygeine practices |
|
Scientific Title of Study
|
Effectiveness of Peer-Led m-health-enabled menstrual hygiene education intervention on improving practices among adolescent girls :a Quasi Experimental Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Vijayavathi |
| Designation |
Postgraduate |
| Affiliation |
Dhanalakshmi Srinivasan medical college and Hospital |
| Address |
Dhanalakshmi Srinivasan medical college and Hospital
Siruvachur, Perambalur
Perambalur
TAMIL NADU
621113
India |
| Phone |
9445293440 |
| Fax |
|
| Email |
drvijivirgo1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalakshmi S |
| Designation |
Professor |
| Affiliation |
Dhanalakshmi Srinivasan medical college and Hospital |
| Address |
Dhanalakshmi Srinivasan medical college and Hospital
Siruvachur, Perambalur
Perambalur
TAMIL NADU
621113
India |
| Phone |
9488625829 |
| Fax |
|
| Email |
Vijilakshmi121@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Vijayavathi |
| Designation |
Postgraduate |
| Affiliation |
Dhanalakshmi Srinivasan medical college and Hospital |
| Address |
Dhanalakshmi srinivasan medical college and hospital,siruvachur
Siruvachur, Perambalur
Perambalur
TAMIL NADU
621113
India |
| Phone |
9445293440 |
| Fax |
|
| Email |
drvijivirgo1988@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Dhanalakshmi srinivasan medical college and hospital,siruvachur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| vijayavathi |
dhanalakshmi srinivasan medical college and hospital |
department of community medicine,3rd floor
Perambalur
TAMIL NADU |
944529440
drvijivirgo1988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee of Dhanalakshmi Srinivasan Medical College, Perambalur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
menstrual hygiene practices |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
peerled mhealth enabled intervention |
standard education and peerled mhealth intervention on menstrual hygiene practices |
| Intervention |
peerled mobile health enabled intervention among school going adolescent girls |
intervention on menstrual hygiene practices on standard health education and mobile health education among school going adolescent girls |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
girls who attained menarche
willing to participate with parents consent |
|
| ExclusionCriteria |
| Details |
Girls with developmental or cognitive impairments
Absence from school during data collection or intervention period
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It will help identify the most effective and feasible approach for menstrual hygiene promotion among adolescents |
comparative evidence on the effectiveness of three menstrual hygiene education strategies |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It will help identify the most effective & feasible approach for menstrual hygiene promotion among adolescents.
|
findings will be useful for scaling up peer-led & digital interventions under national school health programs, |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
25/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To compare effectiveness of standard health education ,peer-led education, mobile health intervention on improving menstrual hygiene practices among school going adolescent girls by conducting pretest and post test,3 schools selected by giving standard education in one school, training to students by peers in second school, third school by mobile app through wats app messages and videos awareness will be given |