| CTRI Number |
CTRI/2025/10/096158 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral
Other (Specify) [Game Based education] |
| Study Design |
Other |
|
Public Title of Study
|
game-based education on knowledge,attitude and practice on menstrual waste disposal and hygiene |
|
Scientific Title of Study
|
A study to assess the effectiveness of game-based education on knowledge, attitude and practice on menstrual waste disposal and hygiene among adolescent girls at selected school of Anand district in view to develop instructional booklet. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ekta Patel |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Nursing Sciences, Karamsad |
| Address |
Room no. 206, Institute of Nursing Sciences, Bhaikaka Univesity, Gokal nagar, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
8347433558 |
| Fax |
|
| Email |
ektapatel501@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ekta Patel |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Nursing Sciences, Karamsad |
| Address |
Room No. 2026, Institute of Nursing Sciences, Bhaikaka Univesity, Gokal nagar, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
08347433558 |
| Fax |
|
| Email |
ektapatel501@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Astha Desai |
| Designation |
M. Sc. Nursing Student |
| Affiliation |
Institute of Nursing Sciences, Karamsad |
| Address |
Classroom no. 207, Institute of Nursing Sciences, Bhaikaka Univesity, Gokal nagar, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9664983920 |
| Fax |
|
| Email |
desaiaaastha07@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Vidhyalay |
| Address |
Mogri Road, Vithal Udyognagar |
| Type of Sponsor |
Other [Higher secondary School as infrastructure support] |
|
|
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 |
| Mr Hemant Dave |
Mahatma Gandhi Vidhyalay |
Mogri Road, Vithal Udyognagar
Anand
GUJARAT |
02692230192
mgmhs@cesociety.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bhaikaka University, Karamsad, Anand, Gujarat |
Approved |
| Bhaikaka University, Karamsad, Anand, Gujarat |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescent girls attended menarche |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Game-based education |
1. Preparation Phase:
Formal permission will be taken from school principals and concerned authorities of selected schools.
Selection of Participants follow by Selected school’s adolescent girls who met the inclusion criteria
will be participate in study after received the Parents or guardians informed consent form outlining all
relevant details of the study.
Simple random sampling technique will be used for randomly assigned the adolescent girls in
experimental group and control group through lottery method where experimental Group will receive
game-based education and control group will not receive the intervention during the study period.
2. Pre-Intervention Phase (Pre-Test Data Collection)
Selected Participants provided sociodemographic structured questionnaire and assess the pre-test for
knowledge, attitude, and practice scores regarding menstrual waste disposal and hygiene using a
validated questionnaire for both the experimental and control groups.
3. Intervention Phase (Game-Based Education Intervention)
Game-Based Educational intervention will Conduct by interactive Snake and Ladder game sessions for
the experimental group through engaging game play and ensure all participants actively participate and
grasp key concepts.
4. Post-Intervention Phase (Post-Test Data Collection)
Post-Test Evaluation: After the intervention, administer the same structured questionnaire will provide
after one week of intervention to both the experimental and control groups.
After Data Collection, assess changes in knowledge, attitude, and practice pretest-posttest scores in
experimental group and Compare post-test scores between the experimental and control groups. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Female |
| Details |
1) Adolescent girls aged between 13 to 15 years.
2) Adolescent girls currently enrolled in school between 8 th to 10 th standard.
3) Adolescent girls have attained stage of menarche.
4) Adolescent girls able to speak, read and write in either Gujarati or English. |
|
| ExclusionCriteria |
| Details |
1) Adolescent girls who have previously participated in intervention studies focused on
menstrual hygiene or waste disposal.
2) Adolescent girls with medical conditions, psychological distress or diagnosed mental health
conditions that may impact their ability to engage in the study.
3) Adolescent girls absent at time of intervention |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of game-based education on knowledge, attitude, and practice regarding menstrual waste disposal and hygiene among adolescent girls. |
Post test will be done after 1 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the knowledge, attitude, and practice of menstrual waste disposal and hygiene among adolescent girls experimental Group and control group before and after game-based educational intervention. |
At baseline data collection and Post test will be done after 1 week. |
| To identify the association between sociodemographic variable and menstrual waste disposal and hygiene among school adolescent girls. |
At baseline data collection and Post test will be done after 1 week. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
03/11/2025 |
| 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="0"
Months="10"
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
|
The present study will aim to evaluate the effectiveness of game-based education using a Snake and Ladder game on knowledge regarding menstrual hygiene and menstrual waste disposal among adolescent girls aged 13–15 years. Participants will be selected using random sampling and divided into experimental and control groups. The experimental group will receive education through the Snake and Ladder game, while the control group will receive conventional teaching. A structured questionnaire based on the Menstrual Practice Needs Scale will be used to assess knowledge levels before and after the intervention. The study will aim to determine whether the game-based method enhances understanding of menstrual hygiene and proper waste disposal. It is expected that post-test knowledge scores of the experimental group will significantly improve, indicating that game-based learning will be an engaging and effective strategy to promote menstrual hygiene awareness and safe waste disposal practices among adolescent girls.
|