| CTRI Number |
CTRI/2023/10/058651 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Virtual Reality in Anatomy |
|
Scientific Title of Study
|
Impact of immersive virtual reality in conceptualization of Anatomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1296-5437 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradip Chauhan |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Rajkot |
| Address |
All India Institute of Medical Sciences Rajkot, Department of Anatomy, Academic Block, Khanderi, Para Pipaliya, Rajkot, Gujarat, India, 360110
Department of Anatomy, Academic Block, Khanderi, Para Pipaliya, Rajkot, Gujarat, India, 360110
Rajkot
GUJARAT
360110
India |
| Phone |
08866199560 |
| Fax |
|
| Email |
prajjawalitresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradip Chauhan |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Rajkot |
| Address |
All India Institute of Medical Sciences Rajkot, Department of Anatomy, Academic Block, Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360110
Department of Anatomy, Academic Block, Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360110
Rajkot
GUJARAT
360110
India |
| Phone |
08866199560 |
| Fax |
|
| Email |
prajjawalitresearch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradip Chauhan |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Rajkot |
| Address |
All India Institute Of Medical Sciences (AIIMS),
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360110
Department of Anatomy, Academic Block, Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360110
Rajkot
GUJARAT
360110
India |
| Phone |
08866199560 |
| Fax |
|
| Email |
prajjawalitresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAJKOT |
|
|
Primary Sponsor
|
| Name |
Dr Pradip Chauhan |
| Address |
Department of Anatomy
All India Institute of Medical Sciences Rajkot, Parapipaliya, Khanderi Road, Rajkot, Gujarat, India |
| 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 Pradip Chauhan |
All India Institute of Medical Sciences Rajkot |
Virtual Reality laboratory, Department of Anatomy,
Khanderi Road, Parapipaliya, Rajkot, Gujarat, India
Rajkot
GUJARAT |
8866199560
prajjawalitresearch@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, Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Knowledge of Anatomy will be measured by pre-test and post-test quizzes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional learning method (2D images and screen based 3D images) |
Learning Material containing 2dimensional digital images (Conventional method) and screen based 3d images to teach the topic. Exposure time: 30 minutes for each topics |
| Intervention |
Learning material compatible to the Immersive Virtual reality |
Learning Material containing virtual interactive 3dimensional models and compatible to the immersive virtual reality for each learning objective. Exposure time: 45 minutes for each learning topic |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
(1) Students securing admission in the first year MBBS at the AIIMS, Rajkot , Gujarat
(2) Students securing admission to First-year MBBS in or after 2021 year
(3) Students cleared NEET (UG) eligibility test in or after 2021 |
|
| ExclusionCriteria |
| Details |
(1) Students not comfortable with using the head-mounted virtual reality devices will be excluded from the study.
(2) Students with any contraindicated condition to use the Head-mounted virtual reality devices. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ability to identify & demonstrate the anatomical position, relations, attachments anatomical concepts.
Will be assessed using post test quizzes |
At the end of the learning session for the specific topic or objective |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Conceptualization of Anatomy for the learning topic |
At the end of the academic session |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/10/2023 |
| Date of Study Completion (India) |
31/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/07/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prajjawalitresearch@gmail.com].
- For how long will this data be available start date provided 19-09-2023 and end date provided 18-09-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This is the Randomized control trial to measure the impact of the immersive virtual reality on the conceptulization of anatomy of the MBBS students .Work Plan: An immersive Virtual reality environment will be created using virtual interactive 3D models developed from the prosected part. Feedback from subject experts will be taken to ensure the accuracy of annotations and external features. Study materials for the models will be created that will include pre-test and post-test assessment questions. The impact on student’s ability to identify anatomical structures and their relations in prosected part will be assessed by the pre-test and post-test. Data will be analyzed by standard statistical methods for study objectives. 1 Detailed methodology including study design and outcome measures Virtual interactive 3D models of prosected part and viscera will be prepared from cadavers. The 3D models will be used to prepare an Immersive Virtual Reality environment which will be compatible in various Virtual Reality devices (e.g. Head-mounted devices,). Not less than 100, MBBS students from AIIMS Rajkot will be enrolled in the study after informed consent. A pre-test will be taken of all students to record the knowledge before learning the topics. On the base of the pre-test score students will be divided into two groups; one group will be considered the control group and the second group will be the interventional group. Both groups will be matched for pre-test score and gender ratio. Students will learn the anatomical structure in the dissection-practical class. The control group will learn with the conventional methods while immersive virtual reality in addition to the conventional method will be provided to the interventional group. All enrolled students will be assessed for the ability to identify the Anatomical structure (e.g. and relations. 2 Data analysis plan: Pre-test and a post-test score of both groups for the femoral triangle and right atrium of the heart will be compiled and analyzed for objectives with standard statistical methods |