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CTRI Number  CTRI/2021/08/035828 [Registered on: 19/08/2021] Trial Registered Prospectively
Last Modified On: 14/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of immersive virtual reality therapy as a part of multimodal approach in modulating pain in patients of burn injury of hands 
Scientific Title of Study   Use of immersive virtual reality therapy as a part of multimodal approach in modulating pain in patients of burn injury of hands. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BALASUBRAMANIYAM C 
Designation  JUNIOR RESIDENT 
Affiliation  JNMCH,AMU 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH,AMU,ALIGARH

Aligarh
UTTAR PRADESH
202002
India 
Phone  9600198005  
Fax    
Email  likeablebala@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  HAMMAD USMANI 
Designation  PROFESSOR 
Affiliation  JNMCH,AMU 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH,AMU,ALIGARH

Aligarh
UTTAR PRADESH
202002
India 
Phone  9897114190  
Fax    
Email  hammadusmani2002@gmail.com  
 
Details of Contact Person
Public Query
 
Name  BALASUBRAMANIYAM C 
Designation  Junior Resident 
Affiliation  JNMCH,AMU 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH,AMU,ALIGARH

Aligarh
UTTAR PRADESH
202002
India 
Phone  9600198005  
Fax    
Email  likeablebala@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH,AMU,ALIGARH  
 
Primary Sponsor  
Name  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CAREJNMCHAMUALIGARH 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH,AMU,ALIGARH  
Type of Sponsor  Government medical college 
 
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 
BALASUBRAMANIYAM C  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,PAIN CLINIC, VR ROOM,AMU,ALIGARH
Aligarh
UTTAR PRADESH 
9600198005

likeablebala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L98||Other disorders of skin and subcutaneous tissue, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GROUP C (CONTROL GROUP)  TO WATCH 3DPLAY IN LAPTOP AND IMMITATE ACTIONS WILL BE ASKED TO RATE NRS PAIN SCALE RATING 0 TO 10 BEFORE AND AFTER 3DPLAY 
Intervention  GROUP VR (IMMERSIVE VIRTUAL REALITY THERAPY)  GROUP VR WILL BE ASKED TO WEAR HMD AND PLAY A 3D GAME IN VR FOR 10MINS AND WILL BE ASKED NRS PAIN SCALE RATING FROM 0 TO 10 BEFORE AND AFTER VR THERAPY 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of burn injury of hands of 2weeks -12 weeks duration.
2. ASA I and II patients, of age varying from 15years to 60 years.
3. No h/o neurological or cognitive dysfunction.
4. Can perform hands movement without assistance 
 
ExclusionCriteria 
Details  1. Patients with amputated limb/phantom limb.
2. H/o susceptibility to motion sickness. 3. History of claustrophobia
4. Patients reported a feeling of anxiety or
discomfort while viewing 3D
environment.
5. Patients with psychiatric illness and
seizure disorders.
6. Burn to face/scalp which prevent use of
HMD.
7. Deaf /visually challenged patients
8. Acute infection.
9. Burn> 30% bodysurface surface area 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
EFFECT OF VR ON PAIN INTENSITY IN PATIENTS OF BURN INJURY OF HANDS  4 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
To explore the efficacy of virtual reality (VR) therapy on:
1. Requirements of analgesics on weekly basis.
2. Patient satisfaction score.
3. Improvement of quality of life using SF-12 Score.
4. Adverse outcome effects.
 
4 WEEKS 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   30/08/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   INTRODUCTION 
Pain is a noxious stimulus which can be interpreted in many ways by different individuals but as yet the mechanism by which body manages it are not completely understood. Though pain is frequently related physical causes(such as inflammatory process and nociceptive transmission of pain messages),the experience is entirely subjective.(1,2) Making Objective measurement of pain difficult. The way in which pain is perceived depends on many factors including past experiences, memory, understanding of pain ,cultural conditioning and pain threshold (6,7)Most of the patients with pain has to undergo significant physical and emotional trauma initially from their injury, subsequently from dressing changes & related treatment they undergo throughout healing phase .Moreover unrelieved pain can produce serious physiological and psychological consequences leading to increased risk of morbidity and state of central sensitisation leading to chronic pain. Virtual reality (VR) can be considered intermediary to reality and computer technology.(8) VR based interventions often have been developed as an adjunctive intervention designed to distract patients for acute pain that has not responded to conventional approaches. (3)Owing to its ability to allow the user to immerse and interact with artificial environment that he/she can visualize ,the game-playing is very engrossing. VR can give patient a perception of actually being in different environment. The rationale for using VR based distraction for acute pain is that since pain requires conscious attention.(4,5)VR draws attention into computer generated world having less attention available to process incoming signals. One of the major challenges of living with persistent pain is that pain is typically increased when patient moves painful body area, the increase in pain that occurs during movement can be substantial and can lead to avoidance and will become fearful of daily activities such as walking, changing from one position to another.(9) VR potentially provides a way of exposing patients to movements that they may avoid because of pain/fear.
MATERIALS AND METHODS
Following approval by board of studies, Department of Anaesthesiology and Critical care and Ethical committee of Jawaharlal Nehru medical College, Aligarh Muslim University, Aligarh. A prospective, randomised, single blind study will be conducted on minimum of 50 patients during year Nov 2019- Nov 2021. All eligible patients will be identified & will divided into two groups of 25 each. Written informed consent will be obtained from each participant.
Primary Objective:
The primary objective is to study the effect of VR on pain intensity in patients of burn injury of hands.

Secondary Objectives:
To explore the efficacy of virtual reality (VR) therapy on:
Requirements of analgesics on weekly basis.
Patient satisfaction score.
Improvement of quality of life using SF-12 Score.
Adverse outcome effects.
RESULT
Study will be started after a few weeks. About mentioned parameters will be recorded and compared
 
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