| CTRI Number |
CTRI/2025/11/097971 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AI Teaching vs Simulated Patient Teaching for Learning Psychiatric History Taking in Nursing Students |
|
Scientific Title of Study
|
A Study to Assess the Effectiveness of AI-Based Teaching Versus Simulated Patient-Based Teaching on Psychiatric History Taking Skills among Undergraduate Nursing Students at Gorakhpur (UP): 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 |
Rishi Kumar |
| Designation |
M.Sc Nursing student |
| Affiliation |
AIIMS, Gorakhpur |
| Address |
College of Nursing,4th Floor, MNC building,AIIMS,Kunraghat,
Gorakhpur
College of Nursing,4th Floor, MNC building,AIIMS,Kunraghat,
Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9356525096 |
| Fax |
|
| Email |
rishi.mahala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Arun Varghese |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Gorakhpur |
| Address |
College of Nursing,4th Floor,MNC building
AIIMS,Kunraghat,Gorakhpur
College of Nursing,4th Floor,MNC building
AIIMS,Kunraghat,Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8194009109 |
| Fax |
|
| Email |
arunvarghese.msc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Arun Varghese |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Gorakhpur |
| Address |
College of Nursing,4th Floor,MNC building
AIIMS,Kunraghat,Gorakhpur
College of Nursing,4th Floor,MNC building
AIIMS,Kunraghat,Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8194009109 |
| Fax |
|
| Email |
arunvarghese.msc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Rishi Kumar |
Colleges of Nursing |
Colleges of Nursing at Kunaraghat,Bashratpur,Padri Bazar and Shahpur Gorakhpur
Gorakhpur
UTTAR PRADESH |
9356525096
rishi.mahala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee,All India Institute of Medical Sciences,Gorakhpur,Uttar Pradesh 273008 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Artificial Intelligence(AI)-based teaching |
Undergraduate nursing students in this group will receive teaching on psychiatric history-taking skills using an AI-based teaching module developed for this study.The AI-based teaching provides interactive,adaptive learning through ChatGPTs voice feature with standardized prompts provided by facilitator to simulate psychiatric patient with various psychiatric conditions, guided responses and automated feedback.Teaching will conducted for total duration of 3-4 hours(divided into sessions),focusing on history taking components such as Demographic details,presenting chief complaints,history of present illness,past psychiatric and medical history,treatment history,family and personal history.Learning will be self paced with faculty supervision and monitored performance tracking by the AI system. |
| Comparator Agent |
Simulated Patient(SPs)-based teaching |
Undergraduate nursing students in this group will be taught psychiatric history-taking skills using simulated patients trained to portray psychiatric cases realistically.Students will interact face-to-face with the simulated patients under supervision of a psychiatric nursing faculty.Each student will perform history-taking interviews covering all key components of psychiatric assessment.
The total duration of teaching will be 3-4 hours,(divided into sessions),focusing on history taking components such as Demographic details,presenting chief complaints,history of present illness,past psychiatric and medical history,treatment history,family and personal history.Feedback will be provided immediately by faculty and the simulated patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
B.Sc.3rd year Undergraduate nursing students
Undergraduate nursing students currently enrolled in the program at nursing colleges of Gorakhpur |
|
| ExclusionCriteria |
| Details |
Not willing to take part
Students with prior formal training in psychiatric history taking |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of Artificial Intelligence (AI)-based teaching versus Simulated Patient (SP)-based teaching on psychiatric history-taking skills among undergraduate nursing students at Gorakhpur. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the students’ skill and knowledge retention in psychiatric history-taking using AI- and SP-based teaching.
To assess the students’ confidence in learning psychiatric history-taking using AI- and SP-based teaching. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2025 |
| Date of Study Completion (India) |
19/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
19/01/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 study aims to evaluate the effectiveness of Artificial Intelligence (AI)-based teaching versus Simulated Patient (SP)-based teaching on psychiatric history-taking skills among undergraduate nursing students at Gorakhpur, Uttar Pradesh. A quantitative, randomized controlled trial design will be used, enrolling 96 third-year B.Sc. Nursing students (48 students per group) from nursing colleges at Gorakhpur, who have not received prior formal psychiatric history-taking training. Participants will be randomly assigned to either the experimental group (AI-based teaching using ChatGPT’s voice feature with standardized prompts) or the control group (SP-based teaching with trained simulated patients portraying psychiatric conditions). Both groups will undergo a structured 4-hour session including pre-briefing/orientation, live demonstration, guided practice, and debriefing. Data will be collected immediately after the intervention and at 1 month, assessing psychiatric history-taking skills, knowledge, and self-confidence using validated checklists and questionnaires. Appropriare analysis will be done. Findings are expected to provide evidence on the comparative effectiveness of AI-based and SP-based teaching, inform evidence-based nursing curriculum innovations, and enhance undergraduate nursing students’ competence in psychiatric history-taking. |