| CTRI Number |
CTRI/2025/03/082014 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [educational training ] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of simulation training of suicide risk assessment among undergraduate medical students |
|
Scientific Title of Study
|
Effectiveness of simulation training of suicide risk assessment among medical students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CSP-MED/24/JAN/97/10 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jazeela Begam Jaheer Hussain |
| Designation |
Psychiatry Junior Resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1, Ramachandra Nagar, Porur
Chennai
Tamil Nadu
600116
India
Chennai
TAMIL NADU
600116
India |
| Phone |
9600631786 |
| Fax |
|
| Email |
jazeelabjh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvarna Jyothi Kanitpudi |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1, Ramachandra Nagar, Porur
Chennai
Tamil Nadu
600116
India
Chennai
TAMIL NADU
600116
India |
| Phone |
9047492143 |
| Fax |
|
| Email |
suvarna@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suvarna Jyothi Kanitpudi |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1, Ramachandra Nagar, Porur
Chennai
Tamil Nadu
600116
India
Chennai
TAMIL NADU
600116
India |
| Phone |
9047492143 |
| Fax |
|
| Email |
suvarna@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Jazeela Begam Jaheer Hussain |
| Address |
No. 1 Ramachandra Nagar, Porur
Chennai
Tamil Nadu
600116
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
Department of Psychiatry, Sri Ramachandra Institute of Higher Education and Research |
No.1, Ramachandra Nagar Porur Chennai
Tamil Nadu
600116
India
Chennai
TAMIL NADU |
904749143
suvarna@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Effectiveness of simulation training in the academic performance of the undergraduate medical students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Simulation video |
A simulation video based on a validated script eliciting suicide risk factors and protective factors, suicidal intention in a confidential and empathetic manner. |
| Comparator Agent |
Traditional teaching method |
A regular didactic class on suicide risk assessment which includes identifying risk and protective factors of suicide, elicitation of suicidal intent. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
undergraduate medical students of year 2 and 3 who are willing participate and give consent |
|
| ExclusionCriteria |
| Details |
Any undergraduate medical student of year 2 and 3 not willing to participate |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate the effectiveness of integrating simulation videos with regular didactic teaching for recognizing suicide risks. |
Baseline and after exposure to the simulation video |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the knowledge & the attitude towards suicide risk assessment with simulation training & regular didactic teaching method |
Baseline & after exposure to intervention |
|
|
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)
|
23/03/2025 |
| 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
|
Aim:
This study aims to evaluate the effectiveness of integrating simulation videos
into the undergraduate medical student training curriculum for recognizing and
managing suicide risks. By comparing students’ knowledge and attitude before
and after exposure to simulation-based training, the study seeks to determine
whether this approach enhances their ability to identify warning signs and
manage suicide risks effectively.
Null
Hypothesis (H0): There is no significant difference in the ability of
under graduate medical students to recognize or manage suicide risks
before and after exposure to simulation videos as part of their training.
Alternate
Hypothesis (H1): The utilization of simulation videos in the training
of under graduate medical students significantly enhances their ability to
recognize and manage suicide risks after exposure compared to their
initial skills before the training.
Study Objectives:
- Assess
baseline knowledge and attitude in recognizing and managing suicide risks
before simulation training.
- Evaluate
the post-training impact of simulation videos on students’ ability to
recognize and manage suicide risks.
- Compare
the performance of students exposed to simulation videos with a control
group using traditional educational methods
|