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CTRI Number  CTRI/2022/05/042608 [Registered on: 17/05/2022] Trial Registered Prospectively
Last Modified On: 12/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effectiveness of Oculus quest and Kinect azure in improving stress, burnout, performance, and quality of life among entrepreneurs 
Scientific Title of Study   Gamification as an entrepreneur well-being intervention: A single-blinded randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Waqar Naqvi 
Designation  Associate Director, Directorate of Research 
Affiliation  NKP Salve Institute of Medical Sciences and Research Centre 
Address  LMH Hospital, Digdoh Hills, Nagpur, Maharashtra, India.
Professor and Head, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.
Nagpur
MAHARASHTRA
440019
India 
Phone  9021699000  
Fax    
Email  waqar@nkpsims.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Waqar Naqvi 
Designation  Associate Director, Directorate of Research 
Affiliation  NKP Salve Institute of Medical Sciences and Research Centre 
Address  LMH Hospital, Digdoh Hills, Nagpur, Maharashtra, India.
Professor and Head, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.
Nagpur
MAHARASHTRA
440019
India 
Phone  9021699000  
Fax    
Email  waqar@nkpsims.edu.in  
 
Details of Contact Person
Public Query
 
Name  Waqar Naqvi 
Designation  Associate Director, Directorate of Research 
Affiliation  NKP Salve Institute of Medical Sciences and Research Centre 
Address  LMH Hospital, Digdoh Hills, Nagpur, Maharashtra, India.
Professor and Head, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.
Nagpur
MAHARASHTRA
440019
India 
Phone  9021699000  
Fax    
Email  waqar@nkpsims.edu.in  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  NKP Salve Institute of Medical Sciences and Research Centre  
Address  NKP Salve Institute of Medical Sciences and Research Centre, Lata Mangeshkar Hospital, Digdoh Hills, Nagpur, Maharashtra-440019 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Waqar Naqvi  NKP Salve Institute of Medical Sciences and Research Centre  Room no. 3, Department of Research, Digdoh Hills, Nagpur, Maharashtra, India-440019.
Nagpur
MAHARASHTRA 
9021699000

waqar@nkpsims.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee, VSPM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  None 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kinect Azure  The Kinect Azure games to be used are Fruit ninja, Just dance 2020, FIFA 15, Your shape, and Brave. 30 minutes gamification module for 3 days per week for 4 weeks. 
Comparator Agent  None  None 
Intervention  Oculus Quest  In Oculus Quest, the games such as Moss, Beat sabre, and Tetris effect will be incorporated. 30 minutes gamification module for 3 days per week for 4 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. He can understand or fluently speak Hindi or English;
2. He is willing and able to give informed consent for participation in the trial.
 
 
ExclusionCriteria 
Details  1. Presence of physical disabilities, which make using the interventions difficult.
2. Self-reported severe psychological or medical disabilities, which make the interventions too confusing (including self-reported dementia).
3. Neurological conditions (eg, Parkinson’s disease, epilepsy, stroke or dementias),
4. Significant visual, auditory or balance impairment;
5. Current receipt of another intensive psychological therapy (or about to start it within the 4-week trial therapy window);
6. Primary diagnosis of alcohol or substance disorder or personality disorder;
7. Unable to watch VR videos (eg, blindness). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Stressors of entrepreneurial employment
2. Burnout measuring scale
3. SF-12  
The questionnaires for evaluating entrepreneurship stress, burnout, quality of life, and performance will be provided at the start of the program and every last day of the training week for 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Pretraining and post-training questionnaire  At baseline, the confidence level of each participant with the device will be assessed using a pretraining questionnaire. The participants will be given the training to use the device. After this, the post training questionnaire will be completed at baseline only. 
Post-intervention questionnaire  A postintervention questionnaire will be conducted after completion of the intervention period i.e. at the end of the 4th week to assess the participant’s perception of the VR platform and its components. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   25/05/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Entrepreneurs usually work for long hours resulting in exhaustion, stress, and burnout. The prevalent symptoms of burnout include reduced levels of physical and mental energy, reduced job efficiency, and diminished productivity. Therefore, it is important to improve the health of entrepreneurs, which can be mediated effectively using gamification. Gamification has a positive relationship with improvements in health and well-being as it influences motivation, positive experiences, and satisfaction. This trial aims to study how 30-minutes of (virtual reality) game use via Kinect Azure and Oculus platforms three times per week, for three weeks, relates to differences in entrepreneur stress, burnout, subjective life quality, and downstream firm performance. Entrepreneurs over the age of 18 to 50 years will be recruited for the gamification analysis. Analysis of previous power using G*Power will be used to determine the sample size. The participants will be divided into 3 groups, wherein Group A will be assigned gamification on the Kinect platform, Group B will be assigned the Oculus Quest intervention, and Group C will be assigned a control condition. Group A and B will undergo a 30 minutes gamification module 3 days per week for 4 weeks at the NKP Salve Institute of Medical Sciences and Research Centre in Nagpur to play games on Kinect and Oculus quest respectively. The outcome measures include a five-point Likert scale for measuring entrepreneurial stress, a burnout measuring scale (BMS) for burnout, a five-point Likert scale for performance, and SF-12 for Quality of life. The questionnaires will be provided at the start of the program and the last day of each training week. Gamification techniques using Kinect Azure and Oculus Quest (i.e., virtual reality) will be integrated into entrepreneur samples to evaluate their impact on improving markers of well-being and in turn, performance. Since current strains pave the way to future accomplishment, entrepreneurs’ eudaimonic well-being might be particularly related to forward-looking challenge stressors and burnouts. The results of this study will provide an insight into how gamification could help entrepreneurs to deal with work stressors, and maintain high well-being.

 
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