CTRI

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CTRI Number

CTRI/2023/03/050897 [Registered on: 20/03/2023] Trial Registered Prospectively

Last Modified On:

18/01/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Behavioral

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

To know the benefits of a computer generated educational training material for learning life saving techniques and checking its uses among entry level college students.

Scientific Title of Study

Development, Implementation and evaluation of virtual reality based basic life support training module among entry level undergraduate students using a mixed methods approach

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Madhura Mohanraji Reddy
Designation	Assistant Professor
Affiliation	Manipal College of Health Professions
Address	Dept. of Respiratory Therapy MCHP,MAHE, Manipal Udupi KARNATAKA 576104 India
Phone	8660196105
Fax
Email	madhura.reddy@manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Krishna HM
Designation	Professor and Head
Affiliation	Kasturba Medical College
Address	Dept. of Anesthesiology, KMC, MAHE, Manipal Udupi KARNATAKA 576104 India
Phone	9448983314
Fax
Email	hm.krishna@manipal.edu

Details of Contact Person
Public Query

Name	Dr Krishna HM
Designation	Professor and Head
Affiliation	Kasturba Medical College
Address	Dept. of Anesthesiology, KMC, MAHE, Manipal Udupi KARNATAKA 576104 India
Phone	9448983314
Fax
Email	hm.krishna@manipal.edu

Source of Monetary or Material Support

Department of Respiratory Therapy, MCHP, MAHE, Manipal. Department of Anesthesiology, KMC, MAHE, Manipal. Dept. of Data Science and computer application, MIT, MAHE, Manipal

Primary Sponsor

Name	Kasturba Medical College
Address	Madhav Nagar, MAHE, Manipal
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 3
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Madhura Reddy	Kasturba medical college	1st floor, Dept. of Anesthesiology, Kasturba hospital, MAHE, Manipal Udupi KARNATAKA	08660196105 madhura.reddy@manipal.edu
Madhura Reddy	Manipal college of health professions	4th floor, room no. 404, dept. of respiratory therapy, manipal college of health professions, MAHE, Manipal Udupi KARNATAKA	8660196105 madhura.reddy@manipal.edu
Madhura Reddy	Manipal Institute of Technology	4th floor, Department of Data Science and computer application, Academic block 4, Manipal institute of technology, MAHE, Manipal Udupi KARNATAKA	08660196105 madhura.reddy@manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee, Kasturba Medical College, MAHE, Manipal, Karnataka, India	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	nil

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	structured traditional training	participants of the control group will receive training through a structured training with the help of PowerPoint presentation and hands on practice on the BLS manikin. traditionally it will take 45 minutes for the theory and skill learning for Basic life support. Participants will undergo training only once.
Intervention	virtual reality based training module.	participants of the intervention group will receive training for basic life support skills with the help of a virtual reality training module. Training through virtual reality would take about half hour for an individual to learn the theory and skills of basic life support. participants will have to undergo training through virtual reality training module only once.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	25.00 Year(s)
Gender	Both
Details	1. Age group of 18 -25 years. 2. All voluntary participants. 3. Entry-level students of health science and non-medical professions institutes.

ExclusionCriteria

Details

1. Participants with prior knowledge/training of BLS and CPR.
2. Participants with intellectual disabilities.
3. Participants with any physical deformities restricting them from performing any skills.
4. Participants with any motion sickness preventing them from using the VR gadgets.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
1. Scores of knowledge and skill of Basic life support	scores will be assessed at baseline, 1 week after intervention, 3 months and 6 months

Secondary Outcome

Outcome	TimePoints
Likert scale scores for attitude and perception	at baseline and 1 week after intervention

Target Sample Size

Total Sample Size="246"
Sample Size from India="246"
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

Phase 2/ Phase 3

Date of First Enrollment (India)

01/08/2023

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="4"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

not yet published

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

A mixed methods approach will be conducted to assess the effectiveness of a virtual reality based module for training the basic life support skills among entry level students. participants from medical and non-medical will be recruited. their knowledge and skills will be assessed at before receiving training, after receiving training and during follow up at 3 months and 6 months. Participants in the intervention group will receive training through virtual simulation. Theoretical and practical knowledge will be given simultaneously. Participants in the control group will receive training through power-point presentation and hands on practice on the manikin. along with knowledge and skills participants will also be assessed for their attitude and perception before and after receiving the intervention. after the evaluation a focused group discussion will be done among the selected participants to get more insights on the experience of the training. analysis of all the results will give insights on the effectiveness of virtual training in acquisition and retention of knowledge and skills over traditional training. it will also let us know whether the virtual training benefits only the medical students who has basic medical background or also benefits non-medical background.

all the data obtained will be analyzed for statistical analysis.