| CTRI Number |
CTRI/2026/01/101002 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Gamification in Breastfeeding Education to promote Right of Choice and Shared Decision-Making among New Mothers and Partners |
|
Scientific Title of Study
|
Gamification in Breastfeeding Education : A Quasi experimental study to promote Autonomy and Shared Decision making among New Mothers and Partners |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Anbupriya |
| Designation |
Associate Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
PT-22, SRM College of Physiotherapy, SRM Medical College, Kattankulathur campus, Chengalpattu district
Chennai
TAMIL NADU
603203
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbupriyam@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Riti Shah |
| Designation |
PG Student |
| Affiliation |
SRM College of Physiotherapy |
| Address |
PT-22, SRM College of Physiotherapy, SRM Medical College, Kattankulathur campus, Chengalpattu district
Chennai
TAMIL NADU
603203
India |
| Phone |
8780960189 |
| Fax |
|
| Email |
rs8323@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Anbupriya |
| Designation |
Associate Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
PT-22, SRM College of Physiotherapy, SRM Medical College, Kattankulathur campus, Chengalpattu district
Chennai
TAMIL NADU
603203
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbupriyam@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, Kattankulathur campus, Chengalpattu district, TN-603203 |
|
|
Primary Sponsor
|
| Name |
SRM College of Physiotherapy |
| Address |
Kattankulathur campus, Chengalpattu district, TN-603203 |
| 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 M Anbupriya |
SRM College of Physiotherapy |
PT-22, SRM College of Physiotherapy, SRM Medical College, Kattankulathur campus, Chengalpattu district
Chennai
TAMIL NADU |
9841549219
anbupriyam@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Breastfeeding postpartum mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gamification in Breastfeeding education |
Participants would be engaged in a structured, guided session featuring gamified breastfeeding education. Two games are : 1. Im just a baby! 2. Mythbusters. with the purpose of educating mothers about appropriate infant’s intake for initial six months. as well as about long known traditional myths and help them differentiate between myths and actual facts.The duration of intervention is 45 minutes
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
1. Primiparous mothers (first-time mothers)
2. Mothers with infants less than one month of age
3. Mothers aged 18 years and above
4. Ability to understand and communicate in the language of the intervention (English or local language)
5. Willingness to participate in the study and provide informed consent
6. Physical presence in the study setting during the recruitment period
|
|
| ExclusionCriteria |
| Details |
1. Mothers with high-risk pregnancies or medical complications that contraindicate breastfeeding, such as HIV/AIDS, active tuberculosis, or other conditions requiring specialized care
2. Infants with diagnosed or expected congenital anomalies or conditions that interfere with breastfeeding, such as cleft lip, cleft palate, or severe prematurity requiring intensive care
3. Mothers with severe mental illness, cognitive impairments, or psychological conditions that would limit their ability to participate meaningfully in the intervention or provide reliable responses
4. Mothers unwilling or unable to provide informed consent due to legal, cognitive, or other reasons
5.Participants who had previously received formal gamified breastfeeding education or similar structured interventions, to avoid contamination of baseline measurements
6. Mothers planning to exclusively formula-feed or those who had already made a firm decision against breastfeeding prior to enrolment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Breastfeeding Self-Efficacy Scale-SF (BSES), MADM
|
At baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This research investigates whether using gamified education methods can improve breastfeeding outcomes compared to traditional teaching approaches for first-time mothers. A quasi-experimental study with pre-post testing will be conducted over 3 months at SRM Hospital and Medical Research Centre’s Obstetrics and Gynecology ward, using convenient sampling to recruit 130 primiparous mothers with infants under 1 month old. Participants will be divided into two groups. The experimental group will receive interactive gamified breastfeeding education featuring quizzes, learning activities, while the control group will receive standard education through written materials and basic instructions. The study will measure changes in breastfeeding knowledge, self-efficacy (using the Breastfeeding Self-Efficacy Scale), maternal autonomy in decision-making, and shared decision-making between mothers and partners, comparing baseline and post-intervention assessments between both groups. This research aims to determine whether gamification can be an effective educational tool to empower new mothers with better knowledge, confidence, and autonomy in their infant feeding decisions, potentially improving breastfeeding rates and experiences. |