| CTRI Number |
CTRI/2025/11/097268 [Registered on: 12/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [EDUCATIONAL] |
| Study Design |
Other |
|
Public Title of Study
|
Educational intervention about Bioethics among medical students. |
|
Scientific Title of Study
|
Bridging the gap: Effect of an intervention on knowledge, attitude, practice of bioethics among medical students . |
| 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 Sai Sankavi R |
| Designation |
Post graduate |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre
College block
Department of Pharmacology(1ST floor)
PG Room
Chennai
TAMIL NADU
603203
India |
| Phone |
9597908321 |
| Fax |
|
| Email |
ss4838@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satya Narayanan |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre
College block
Department of Pharmacology(1st floor)
Chennai
TAMIL NADU
603203
India |
| Phone |
9384633405 |
| Fax |
|
| Email |
ss4838@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Sankavi R |
| Designation |
Post graduate |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre
College block
Department of Pharmacology(1st floor)
PG Room
Chennai
TAMIL NADU
603203
India |
| Phone |
9597908321 |
| Fax |
|
| Email |
ss4838@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre
Department of Pharmacology |
|
|
Primary Sponsor
|
| Name |
SRM Medical College |
| Address |
SRM Medical College Hospital and Research Centre
College block
Department of Pharmacology(1ST floor)
PG Room
kattankulathur campus
603203 |
| Type of Sponsor |
Private medical college |
|
|
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 Sai Sankavi R |
SRM Medical College Hospital and Research Centre |
SRM Medical College Hospital and Research Centre
College block
Department of Pharmacology(1ST floor)
PG Room
kattankulathur campus
603203
Chennai
TAMIL NADU |
09597908321
ss4838@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM INTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioethics workshop |
Bioethics workshop conducted followed by post-test |
| Comparator Agent |
Bioethics workshop |
Pre-test before workshop |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
All MBBS students from 1st year to final year |
|
| ExclusionCriteria |
| Details |
Non–undergraduate students
Students not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| significant improvement in marks among students’ knowledge, attitudes, and practices regarding bioethics across all four years |
Pre workshop, immediately after workshop |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="545"
Sample Size from India="545"
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)
|
01/12/2025 |
| 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 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
|
BRIDGING THE GAP: Effect of an Intervention on Knowledge, Attitude and Practice of Bioethics among Medical Students” explores the current state of bioethics awareness among MBBS students at SRM Medical College, Chennai, and evaluates the impact of a targeted educational workshop. Recognizing bioethics as essential for future physicians — underpinning principles like autonomy, beneficence, non-maleficence and justice — the study addresses a perceived gap between curricular exposure and practical ethical competence in clinical scenarios. Using a one-group pre-test/post-test design over three months, students from all years completed a standardized KAP questionnaire before and after the workshop. The objectives were to assess knowledge levels, examine how knowledge relates to attitudes and practices, and explore demographic influences such as year of study or prior training. Findings are intended to highlight educational gaps and support improved curriculum strategies, aiming to nurture ethically responsible, patient-centred medical professionals. |