| CTRI Number |
CTRI/2025/11/097890 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [educational project] |
| Study Design |
Other |
|
Public Title of Study
|
Implementation of new teaching methods in undergraduate student in ENT department for there better learning |
|
Scientific Title of Study
|
Mapping and Implementation of Entrustable Professional Activities (EPAs) in Undergraduate ENT Training: A Pilot Study |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srilatha Kavarthapu |
| Designation |
Associate Professor |
| Affiliation |
Manipal Tata Medical college, Jamshedpur |
| Address |
DEPT of ENT,Manipal Tata Medical College, Baridih, Jamshedpur
Purbi Singhbhum JHARKHAND 831017 India |
| Phone |
09502856287 |
| Fax |
|
| Email |
srilatha.k@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Srilatha Kavarthapu |
| Designation |
Associate Professor |
| Affiliation |
Manipal Tata Medical college, Jamshedpur |
| Address |
Dept of ENT, Manipal Tata Medical College, Baridih, Jamshedpur
Purbi Singhbhum JHARKHAND 831017 India |
| Phone |
09502856287 |
| Fax |
|
| Email |
srilatha.k@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Srilatha Kavarthapu |
| Designation |
Associate Professor |
| Affiliation |
Manipal Tata Medical college, Jamshedpur |
| Address |
Dept of ENT, Manipal Tata Medical College, Baridih, Jamshedpur
Purbi Singhbhum JHARKHAND 831017 India |
| Phone |
09502856287 |
| Fax |
|
| Email |
srilatha.k@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Tata Medical College |
|
|
Primary Sponsor
|
| Name |
srilatha K |
| Address |
Dept Of ENT, Manipal Tata Medical College,Jamshedpur,Jharkhand,India 831017 |
| 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 |
| Dr Srilatha K |
Manipal Tata Medical College |
Dept of ENT, Manipal Tata Medical College, Baridih, Jamshedpur Purbi Singhbhum JHARKHAND |
09502856287
srilatha.k@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MTMC Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Entrustable Professional Activities-An Entrustable Professional Activity (EPA) is a key task of a profession that can be fully entrusted to a trainee once they have demonstrated the necessary competence to perform it independently, without direct supervision.students will be taught initially later they will be assessed if they can perform independently |
To assess the feasibility, acceptability, and effectiveness of EPA-based training among students and faculty. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
a) MBBS students posted in ENT during the study period
b) ENT faculty involved in undergraduate clinical teaching
|
|
| ExclusionCriteria |
| Details |
Students who are not willing to participate in the study will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The feasibility, acceptability, and effectiveness of implementing EPA-based training in undergraduate ENT education. |
baseline, at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
02/12/2025 |
| 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="3" 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
|
JustificationWhile
EPAs are widely implemented in postgraduate medical training internationally,
there is limited research on their role in undergraduate ENT education in
India.
This
study addresses the gap by piloting the adaptation and implementation of EPAs
tailored to ENT teaching in a competency-based curriculum framework. |