| CTRI Number |
CTRI/2025/10/095773 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Integrated Simulation Training on Delirium Among Undergraduate Medical Students: A Randomized Controlled Study. |
|
Scientific Title of Study
|
Effectiveness of integrated simulation training on delirium among undergraduate medical students a randomised controlled study |
| Trial Acronym |
SIMDEL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pattipati VenkataLakshmi Sahithi |
| Designation |
Psychiatry Resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Ladies hostel 6, Sri Ramachandra medical college, No 1 Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
7022227623 |
| Fax |
|
| Email |
m2623002@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvarna Jyothi Kantipudi |
| Designation |
MBBS,DPM,MD Psychiatry, MPH |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Staff quarters F block, Sri Ramachandra medical college, No 1 Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9047492143 |
| Fax |
|
| Email |
suvarna@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suvarna Jyothi Kantipudi |
| Designation |
MBBS,DPM,MD Psychiatry, MPH |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Staff quarters, F block, Sri Ramachandra medical college,No 1 Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9047492143 |
| Fax |
|
| Email |
suvarna@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Pattipati VenkataLakshmi Sahithi |
| Address |
Sri Ramachandra Institute of Higher Education and Research |
| 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 |
| Pattipati VenkataLakshmi Sahithi |
Sri Ramachandra Institute of Higher Education and Research- Sri Ramachandra medical college |
No 1 Sri Ramachandra nagar, Porur
Chennai
TAMIL NADU |
7022227623
m2623002@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Didactic lecture with a handout. |
Participants will be given a didactic lecture on delirium followed by handouts of the same. |
| Intervention |
Simulation videos with discussion. |
Participants will be shown simulation videos on delirium followed by active discussion on the same. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Students at SRIHER who are in MBBS phase 2 and willing to participate in the study with informed consent. |
|
| ExclusionCriteria |
| Details |
Students not studying at SRIHER.
Students not willing to participate in the study.
Students undergone training in delirium assessment in the past. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in knowledge scores from pre- to post-intervention in both groups measured using a validated questionnaire, and comparison of the degree of improvement between the groups. |
Improvement in knowledge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in attitude scores toward delirium from pre- to post-intervention in both groups, measured by a validated questionnaire, with comparison between groups.
Improvement in confidence scores regarding delirium from pre- to post-intervention in both groups, measured by a validated questionnaire, with comparison between groups. |
Improvement in attitude towards delirium & confidence regarding delirium. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
10/11/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 is an RCT where participants based on inclusion criteria will be randomly assigned to 2 groups of which group A will receive didactic lecture on delirium followed by handouts and group B will receive simulation video followed by discussion on the same. Participants knowledge and confidence will be assessed through pre and post tests along with their attitude towards the condition.Statistical analysis will evaluate changes in knowledge, confidence and attitude between the groups. |