| CTRI Number |
CTRI/2026/02/102768 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare Moulage-Based Simulation and Traditional Teaching for Improving Nursing Students’ Skills in Assessing Psychiatric Patients with Physical Abuse |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Evaluate the Effectiveness of Moulage-Based Simulation vs Conventional Teaching in Enhancing Nursing Students Competencies in the Assessment of Psychiatric Patients with a History of Physical Abuse. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reeta Devi |
| Designation |
Msc Nursing Student & Registered Nurse and Midwife |
| Affiliation |
College of Nursing AIIMS Gorakhpur |
| Address |
College of Nursing AIIMS Gorakhpur
Deoria Road kurnraghat gorakhpur 273008 UP
College of Nursing AIIMS Gorakhpur
Deoria Road kurnraghat gorakhpur 273008 UP
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8278777982 |
| Fax |
8278777982 |
| Email |
reetav22277@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reeta Devi |
| Designation |
Msc Nursing Student & Registered Nurse and Midwife |
| Affiliation |
College of Nursing AIIMS Gorakhpur |
| Address |
College of Nursing AIIMS Gorakhpur
Deoria Road kurnraghat gorakhpur 273008 UP
College of Nursing AIIMS Gorakhpur
Deoria Road kurnraghat gorakhpur 273008 UP
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8278777982 |
| Fax |
8278777982 |
| Email |
reetav22277@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reeta Devi |
| Designation |
PG Nursing Student |
| Affiliation |
College of Nursing AIIMS Gorakhpur |
| Address |
College of Nursing AIIMS Gorakhpur
Deoria Road kurnraghat gorakhpur 273008 UP
College of Nursing AIIMS Gorakhpur
Deoria Road kurnraghat gorakhpur 273008 UP
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8278777982 |
| Fax |
8278777982 |
| Email |
reetav22277@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
College of Nursing AIIMS Gorakhpur |
| Address |
College of Nursing AIIMS Gorakhpur AIIMS Gorakhpur 273008 |
| Type of Sponsor |
Government 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 |
| Mr Arun Varghese |
College of Nursing AIIMS Gorakhpur |
Department of Psychiatric Nursing,
College of Nursing,AIIMS Gorakhpur
MNC Building,
Skill Lab, 4th Floor,
Gorakhpur, Uttar Pradesh, India
Gorakhpur
UTTAR PRADESH |
8194009109
8194009109
arunvarghese.msc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC AIIMS GORAKHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy & living |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Teaching Method |
The conventional classroom teaching will be used as the comparator. It will consist of lectures and discussion sessions without the use of moulage or simulation techniques. The frequency and duration of the sessions will be similar to the intervention group as per study protocol. |
| Intervention |
Moulage-Based Simulation |
A moulage-based simulation training will be conducted as an educational intervention. The intervention will consist of one session of 3 hours duration, conducted once during the study period. The total duration of the intervention will be a single day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Undergraduate BSc Nursing students in their 3rd or 4th semester
Students currently undergoing psychiatric clinical training
Students willing to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
Students with prior clinical experience in assessing psychiatric patients with physical abuse
Students who have received previous formal training on physical abuse assessment
Students unwilling to participate or absent during intervention sessions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in assessment competencies of nursing students in identifying physical abuse among psychiatric patients, which will be measured using a structured competency/skill assessment checklist. |
The outcomes will be assessed at specific time points as planned:
At baseline (before the intervention),
Immediately after the intervention,
One month after the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in confidence levels of nursing students in assessing psychiatric patients with physical abuse.
Improvement in knowledge retention related to physical abuse assessment among psychiatric patients. |
Baseline (pre-test)
Immediately post-intervention
One month after intervention (for retention) |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
12/02/2026 |
| 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="1"
Days="30" |
|
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
|
This randomized controlled trial aims to evaluate the effectiveness of moulage based simulation compared to conventional teaching in enhancing nursing students competencies in the assessment of psychiatric patients with a history of physical abuse. Undergraduate nursing students will be randomly allocated into two groups. The intervention group will receive moulage based simulation training while the control group will receive conventional teaching. The outcomes will be assessed using structured assessment tools. |