| CTRI Number |
CTRI/2026/04/107312 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving Oral Health Knowledge, Attitude, Confidence, and Referral Practices of ASHA Workers Through Multimedia Education |
|
Scientific Title of Study
|
Effectiveness of multi-media based intervention on knowledge, self-efficacy and referral practice of ASHA workers about Oral Health- A field trial. |
| 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 Kavana |
| Designation |
Post graduate student |
| Affiliation |
M S Ramaiah University of Applied Sciences |
| Address |
Room 5,Faculty of dental sciences, Ramaiah university of applied sciences, MSR nagar, Bengaluru
Room 5,Faculty of dental sciences, Ramaiah university of applied sciences, MSR nagar, Bengaluru
Bangalore
KARNATAKA
560054
India |
| Phone |
9008118773 |
| Fax |
|
| Email |
kavanasri5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shwetha K M |
| Designation |
Associate Professor |
| Affiliation |
M S Ramaiah University of Applied Sciences |
| Address |
Room 5, Faculty of dental sciences, Ramaiah university of applied sciences, MSR nagar, Bengaluru
Room 5, Faculty of dental sciences, Ramaiah university of applied sciences, MSR nagar, Bengaluru
Bangalore
KARNATAKA
560054
India |
| Phone |
9845224049 |
| Fax |
|
| Email |
shwetha.pl.ds@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavana |
| Designation |
Post graduate student |
| Affiliation |
M S Ramaiah University of Applied Sciences |
| Address |
Room 5,Faculty of dental sciences, Ramaiah university of applied sciences, MSR nagar, Bengaluru
Room 5,Faculty of dental sciences, Ramaiah university of applied sciences, MSR nagar, Bengaluru
Bangalore
KARNATAKA
560054
India |
| Phone |
9008118773 |
| Fax |
|
| Email |
kavanasri5@gmail.com |
|
|
Source of Monetary or Material Support
|
| M S RAMAIAH UNIVERSITY OF APPLIED SCIENCES, NEW BEL ROAD, MSR NAGAR, BANGALORE |
|
|
Primary Sponsor
|
| Name |
M S RAMAIAH UNIVERSITY OF APPLIED SCIENCES |
| Address |
ROOM 5, FACULTY OF DENTAL SCIENCES, NEW BEL ROAD, MSR NAGAR, BANGALORE |
| Type of Sponsor |
Other [PRIVATE UNIVERSITY] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavana S |
Primary Health Centre |
Meeting Room , PHC Chinnasandra Village, Chintamani Taluk, Chikballapur District,Karnataka
Kolar
KARNATAKA |
09008118773
drkavana111@gmail.com |
| Dr Kavana S |
Primary Health Centre |
Meeting room, primary health centre , kaiwara village, Chintamani taluk, Chikkaballapur district
Kolar
KARNATAKA |
09008118773
drkavana111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| District Health and Family Welfare |
Approved |
| UNIVERSITY ETHICS COMMITTEE FOR HUMAN TRIALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal- ASHA workers for health education |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional method |
This group will follow the standard methodology typically used in government training programs for ASHA workers.
In addition to this, the intervention will include supplementary printed materials such as Booklets and leaflets designed to provide structured and reliable oral health education.
The booklets contain comprehensive guides on oral hygiene, diet and oral health, common dental issues, and preventive care and are illustrated step-by-step instructions.
|
| Intervention |
Multimedia Based Approach |
A mobile application for android phones is a digital tool designed to provide interactive and easily accessible oral health education. This app will be available in the local language, making it more relatable and easier to understand for the target audience.
This app leverages digital accessibility to make oral health education engaging and widely available.
In addition to the app, other multimedia reinforcement tools will be integrated to enhance engagement and learning.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. ASHA workers with at least one year of experience
2. Owning or having access to a smartphone (for mobile app intervention)
|
|
| ExclusionCriteria |
| Details |
People who are under contract |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the knowledge, attitude and self-efficacy of ASHA workers before and after the intervention to assess its impact. |
Baseline, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess referral practices of ASHA workers regarding oral diseases. |
4 weeks, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/05/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to evaluate the effectiveness of a multi-media based oral health education intervention compared with conventional training methods among Accredited Social Health Activists (ASHA workers). This research assesses changes in oral health knowledge, self-efficacy, and referral practices following the interventions. Assessments using WHO KAP questionnaires, a validated self-efficacy tool, and referral records will be conducted at baseline, one month, and three months. The study seeks to determine whether digital training offers superior or comparable improvements over traditional methods, with implications for strengthening community-based oral health promotion and referral systems. |