| CTRI Number |
CTRI/2025/12/099628 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [intervention is methods of teaching - simulation based or regular bedside clinics] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
simulation based teaching vs regular teaching on alcohol related competencies in mbbs students |
|
Scientific Title of Study
|
EFFECTIVENESS OF INTEGRATED SIMULATION BASED TEACHING VERSUS REGULAR TEACHING ON ALCOHOL-RELATED COMPETENCIES IN MEDICAL STUDENTS: A RANDOMIZED CONTROLLED 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 AYUSH DUBEY |
| Designation |
ACADEMIC JUNIOR RESIDENT |
| Affiliation |
Sri ramachadra institute of higher education and research |
| Address |
Department of psychiatry , Sri Ramachandra medical college hospital and research centre, Porur , Chennai
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
8870983648 |
| Fax |
|
| Email |
ayushdubey971@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvarna Jyothi Kantipudi |
| Designation |
Professor and Unit Chief |
| Affiliation |
Sri ramachadra institute of higher education and research |
| Address |
Department of psychiatry , Sri Ramachandra medical college hospital and research centre, Porur , Chennai
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9047492143 |
| Fax |
|
| Email |
suvarna@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suvarna Jyothi Kantipudi |
| Designation |
Professor and Unit Chief |
| Affiliation |
Sri ramachadra institute of higher education and research |
| Address |
Department of psychiatry , Sri Ramachandra medical college hospital and research centre, Porur , Chennai
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9047492143 |
| Fax |
|
| Email |
suvarna@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Medical College and Research Institute, SRIHER, Porur, Chennai-600116, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Dr Ayush Dubey |
| Address |
Room no 23, first floor , Department of psychiatry, Sri Ramachandra Hospital ( g block) and Research Institute, SRIHER, Porur, Chennai-600116, Tamil Nadu |
| 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 Suvarna Jyothi Kantipudi |
Sri Ramachandra medical college Hospital ( G block) and research institute |
Room no 23 , first floor , Department of Psychiatry, SRIHER, Porur, Chennai-600116, Tamil Nadu
Thiruvallur
TAMIL NADU |
9047492143
suvarna@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil problems |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Regular bedside teaching on alcohol related competencies |
Other group of students will be given regular bedside teaching on alcohol related competencies according to NMC Guidelines |
| Intervention |
simulation teaching on alcohol related competencies in MBBS students |
mbbs students will be given simulation based teaching for Alcohol related competencies as listed by the NMC guidelines |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
All MBBS students who are willing to consent in the study will be enrolled |
|
| ExclusionCriteria |
| Details |
MBBS students who have already been trained in alcohol related competencies will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in the knowledge of MBBS students pre and post bedside teaching vs simulation teaching in alcohol related competencies |
in index visit , pretest will be conducted , simulation teaching/ bedside teaching will be given and post test will be conducted on the same day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in attitudes, skills of MBBS students post bedside teaching and simulation teaching in alcohol related |
change in attitudes and skills will be measured on the same day as enrolment of students |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/12/2025 |
| 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
|
The study will begin with recruiting MBBS students attending psychiatry postings in Sri Ramachandra medical college . Students who haven’t received prior training in the area of alcohol related competencies and who are willing to participate will be recruited . Initially a pretest will be administered which will consist of a set of 10 MCQs based on the different knowledge competencies listed by NMC on alcohol use disorder .subsequently the students will receive a didactic lecture based on the Knowledge competencies by NMC in alcohol use disorder . Subsequently the students will be then randomised into 2 groups using computer generated random numbers - with group a getting regular bedside teaching and the Group B getting simulation teaching with debriefing . Each group would then be administered a post test ( set of 10 MCQ questions ) , and an objective type assessment for change in attitudes regarding alcohol related competencies . Finally all students will be also given an OSCE station based on Alcohol related competencies where the skills acquired by them will be evaluated . The examiner of the OSCE station would be blinded in the study . Analysis will be done using SPSS and results will be interpreted . |