| CTRI Number |
CTRI/2025/12/098972 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on menstrual hygiene awareness and practices among school girls |
|
Scientific Title of Study
|
Communication, Practice and Policy: A Comprehensive Study on Menstrual
Hygiene Among School Girls |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sparsha Jain |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Institute Of Communication |
| Address |
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8498833893 |
| Fax |
|
| Email |
sparsha.micmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sparsha Jain |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Institute Of Communication |
| Address |
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8498833893 |
| Fax |
|
| Email |
sparsha.micmpl2023@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjushree G Naik |
| Designation |
Associate Professor |
| Affiliation |
Manipal Institute Of Communication |
| Address |
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9886445562 |
| Fax |
|
| Email |
manjushree.naik@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education (MAHE), Manipal Institute of Communication, Manipal, Karnataka |
|
|
Primary Sponsor
|
| Name |
Sparsha Jain |
| Address |
Manipal Institute Of Communication, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sparsha Jain |
Government and Private Schools – Bengaluru Urban District |
Bengaluru Urban District, Karnataka, India
Bangalore
KARNATAKA |
8498833893
sparsha.micmpl2023@learner.manipal.edu |
| Sparsha Jain |
Government and Private Schools – Hassan District |
Hassan District, Karnataka, India
Hassan
KARNATAKA |
8498833893
sparsha.micmpl2023@learner.manipal.edu |
| Sparsha Jain |
Government and Private Schools – Udupi District |
Udupi District, Karnataka, India
Udupi
KARNATAKA |
8498833893
sparsha.micmpl2023@learner.manipal.edu |
| Sparsha Jain |
Government and Private Schools – Yadgir and Gulbarga District |
Gulbarga District, Karnataka, India
Gulbarga
KARNATAKA |
8498833893
sparsha.micmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menstrual hygiene awareness, attitudes, and practices among school-going adolescent girls |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
Girls aged 10–19 years who have attained menarche, enrolled in selected government and private schools in Karnataka, providing written assent and parental consent, and present on the day of data collection. |
|
| ExclusionCriteria |
| Details |
Girls younger than 10 or older than 19 years; students who have not yet attained menarche; absent on the day of data collection; refusal of assent or lack of parental consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the proportion of adolescent school girls who demonstrate adequate menstrual hygiene knowledge and hygienic menstrual practices, as assessed through a structured survey tool. |
As this is a cross-sectional study, the primary outcome is assessed at a single time point only. Each participant will be surveyed once during the one-year data-collection period; therefore, the outcome is estimated only at the time of survey administration (i.e., no baseline or follow-up assessments such as 4 or 8 weeks). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="694"
Sample Size from India="694"
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)
|
22/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study aims to assess menstrual hygiene knowledge, attitudes and hygienic practices among school going adolescent girls in Karnataka. It also examines the communication strategies used by schools and health authorities to promote menstrual hygiene and evaluates existing policies and implementation gaps related to menstrual hygiene management. The study uses a mixed methods design with a cross sectional survey of students, key informant interviews with teachers and health staff, and analysis of national and state level policy documents. There is no intervention. The findings will help identify gaps in awareness, communication and school facilities and provide evidence to strengthen menstrual hygiene programs and policy implementation. |