| CTRI Number |
CTRI/2024/05/067913 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational Randomized Control Trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Virtual reality simulation for teaching medical undergrdauates |
|
Scientific Title of Study
|
Comparison of virtual reality simulation and traditional teaching in acquisition and retention of ECG interpretation skills among undergraduate students - a randomized control 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 NAYYAR IQBAl |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Dept Of Medical Education
PIMS
Kalapet
Pondocherry
605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9629180164 |
| Fax |
|
| Email |
drinayyar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NAYYAR IQBAl |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Dept Of Medical Education
PIMS
Kalapet
Pondocherry
605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9629180164 |
| Fax |
|
| Email |
drinayyar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NAYYAR IQBAl |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Dept Of Medical Education
PIMS
Kalapet
Pondocherry
605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9629180164 |
| Fax |
|
| Email |
drinayyar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences, Kalapet, Puducherry, 605014 |
|
|
Primary Sponsor
|
| Name |
Nayyar Iqbal |
| Address |
Dept of Medical Education
PIMS
Kalapet, Puducherry 605014
Puducherry |
| 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 Nayyar Iqbal |
Pondicherry Institute of Medical Sciences |
Department of Medical Education
Kalapet
Puducherry 605014
Pondicherry
PONDICHERRY |
9629180164
drinayyar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMSIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Traditional Teaching |
Traditional teaching in classroom using chalk and board. 1 hour per day for 5 days in week for 4 weeks |
| Intervention |
Virtual Reality Teaching |
Students were exposed to Virtual reality teaching of ECG for 1 hour per day, five days in a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
27.00 Year(s) |
| Gender |
Both |
| Details |
all students who are studying in 8th semester of MBBS curriculum and has passed their 3rd year subjects were included in the study |
|
| ExclusionCriteria |
| Details |
1st year, 2nd year and Students who failed in 3rd year of MBBS were excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in knowledge in interpretation skills of ECG |
At the start of the study (Base line) At 6 weeks and then at 14 weeks from the start of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Retention of knowledge in interpretation skills of ECG |
2 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
06/06/2024 |
| 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="4"
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 Electrocardiogram (ECG) is one of the most important tools to diagnose cardiac abnormality particularly arrhythmias and myocardial infarction. It is one of the certifiable competencies for final-year medical undergraduate students. We determined Virtual reality’s effectiveness in acquiring and retaining ECG interpretation skills among medical students compared to traditional teaching. Methods: One hundred and forty students were randomized into two groups. Seventy-one students (immersion group) were trained using virtual reality simulation to acquire and retain interpretation skills of normal and abnormal ECG. Sixty-nine students (traditional group) were trained in the classroom using chalk and board. The primary outcome of change in acquiring knowledge of the interpretation of ECG was determined by comparing pre and post-test scores. The secondary outcome of retention of knowledge was determined by comparing pre-test and second post-test scores conducted after eight weeks of intervention. The p-value of < 0.05 was considered significant. |