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
|
|
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
|
|
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 |