| CTRI Number |
CTRI/2024/03/064887 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [changes in literacy level] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Menstrual Health and Hygiene related educational intervention is developed and used to improve knowledge and practices of adolescent girls |
|
Scientific Title of Study
|
Effectiveness of Evidence-informed Menstrual health emPOWERment ( EMPOWER) program on menstrual health literacy and menstrual health practice among adolescent girls residing in Child Care Institutions of Dakshina Kannada district : a Developmental research |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Precilla Dsilva |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Nursing |
| Address |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru
Manipal College of Nursing
Manipal Academy of Higher Education
Manipal 576014
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9731873891 |
| Fax |
|
| Email |
precilladsilva25@fathermuller.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baby S Nayak |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576014
India |
| Phone |
9448174791 |
| Fax |
|
| Email |
baby.s@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Precilla Dsilva |
| Designation |
PhD Scholar |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9731873891 |
| Fax |
|
| Email |
precilladsilva25@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Child Care Institutions of Dakshina Kannada district |
| Father Muller College of Nursing Mangaluru |
| Manipal College of Nursing MAHE Manipal |
|
|
Primary Sponsor
|
| Name |
Precilla Dsilva |
| Address |
Father Muller College of Nursing Father Muller Road
Kankanady |
| Type of Sponsor |
Other [self funded ] |
|
|
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 |
| Dr Sudheer Prabhu |
Balikashrama Child care Institution |
Balikashrama Road
Kankanady, Mangalore
Dakshina Kannada District
Mangaluru
Dakshina Kannada
KARNATAKA |
9902331559
sudhirhaladi@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Comitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescent girls |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EMPOWER programme |
• Interventional package includes knowledge about safe menstrual health, hygienic practices, management of menstrual discomfort by following good nutrition, relaxation methods and improving the overall wellbeing
• It will be delivered in the same residential space for a time duration of 45-60 mins by the investigator in three settings and follow up will be done three times i.e 1st, 3rd and 6th month. This is for intervention group
|
| Comparator Agent |
Standard care |
Control group will not receive any intervention till the investigator completes the final data collection. After the compilation of final data control group will also receive same educational module as of intervention group |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Female |
| Details |
Adolescents who are able to read and write English or kannada and attained menarche with the specified age group will be included for this study |
|
| ExclusionCriteria |
| Details |
Adolescents: Children with a history of any known psychiatric illness and juveniles in conflict with law |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Menstrual Health Literacy and Safe Menstrual Practices |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Menstrual Discomfort & overall Well Being |
6 months |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
05/04/2024 |
| 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="4"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
not yet completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Menstrual health and Hygiene is one of the key component in each adolescent girls life. Adequate knowledge on Menstrual Health helps to cultivate safe practices thus contributing to the reproductive health.The Present study tries to develop a intervention package which helps to improve the overall well being of the adolescent specially during menstruation with the help of evidence based studies
|