| CTRI Number |
CTRI/2025/02/080797 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [mobile app] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Smartphone application in terms of Knowledge, practice and beliefs regarding menstruation among the adolescent girls of selected schools. |
|
Scientific Title of Study
|
Effectiveness of Technology-based Menstrual Health Intervention Package T-MHIP on Knowledge on Menstrual Health, self-reported Hygienic Practices, Menstrual Discomforts and Beliefs among the adolescent girls of Sikkim: Cluster Randomized Control Trial |
| Trial Acronym |
TMHIP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonam Zangmu Sherpa |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal College of Nursing |
| Address |
Sikkim Manipal College of Nursing Level 2
Dept of OBG Nursing, room no 8
Sikkim Manipal University
5th mile Tadong
East
SIKKIM
737102
India |
| Phone |
8348778917 |
| Fax |
|
| Email |
sonamzangmu.s@smims.smu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baby S Nayak |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing
Dept of Child Health Nursing
level 2,Room no. 201
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9632217067 |
| Fax |
|
| Email |
baby.s@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binu Margaret |
| Designation |
Assistant Professor Selection grade |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing
Dept of Child Health Nursing
Level 1, room no 105
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binu.m@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Sikkim Manipal College of Nursing
Sikkim Manipal University
Gangtok, Sikkim |
|
|
Primary Sponsor
|
| Name |
Mrs Sonam Zangmu Sherpa |
| Address |
Sikkim Manipal College of Nursing
Sikkim Manipal Univeristy
5th mile Tadong, Gangtok, Sikkim, 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 |
| Ms Sonam Zangmu Sherpa |
Sikkim Manipal Institute of Medical Sciences |
Sikkim Manipal College of Nursing
Dept of OBG
2nd Floor, CRH building
Room No 207
East
SIKKIM |
8348778917
snmsherpa5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescent Girls and their mothers:
1. with either low Knowledge (75%), poor self-reported Hygienic Practices or negative beliefs related to menstruation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Educational material |
Educational material will be provided to the control group. The adolescent girls from control group will also be followed up at 1 months, 3 months and 6 months. |
| Intervention |
Technology-based Menstrual Health Intervention Package T-MHIP |
The duration of the intervention will be 2 hours. The adolescent girls will then be followed up at 1 month, 3 months and 6 months of usage of menstrual app |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Female |
| Details |
Phase I
•Are studying in government schools from urban and rural areas of Gangtok district, Sikkim
•have attained menarche and had at least two consecutive menstrual cycles.
For mothers: mothers of adolescent girls having poor belief regarding menstruation
Phase II
1.with either low Knowledge, poor self-reported Hygienic Practices or negative beliefs regarding menstruation
2.availability of smart phones either with adolesnent girls or with mothers
3.accessibility and permission to use mother’s mobile phones
|
|
| ExclusionCriteria |
| Details |
For Phase I:
Adolescent who
are not willing to participate in the study and who do not have parental consent
does not stay with parents
•are not available during the data collection period
For phase II
The study will exclude all adolescent girls
1. mothers and adolescent girls when not available during the data collection
2. who do not have smart phones
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in knowledge, self-reported hygienic practices, decreased menstrual discomforts and positive beliefs regarding menstruation |
1 month, 3 months and at 6 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| utilizing menstrual app with ease and comfort |
Ongoing follow-up at 1 month, 3 months and 6 months.
|
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 2 |
|
Date of First Enrollment (India)
|
18/02/2025 |
| 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
|
The study will be carried out in two phases. In the 1st phase: Objectives: 1) assess the knowledge on menstrual health and self-reported hygienic practices followed during menstruation by the adolescent girls . 2) assess menstrual discomforts faced by the adolescent girls. 3) assess the beliefs regarding menstruation among the adolescent girls 4) explore the beliefs of the mothers of adolescent girls having poor belief regarding menstruation. In 2nd phase:
1) to develop and validate technology-based menstrual health intervention package (T-MHIP) 2) find the effectiveness of T-MHIP in terms of changes in the knowledge, self reported hygienic practices, menstrual discomforts and beliefs regarding menstruation among adolescents and knowledge and beliefs of mothers. 3) assess the acceptability and usability of T-MHIP.
|