Use of immersive virtual reality therapy as a part of multimodal approach in modulating pain in patients of burn injury of hands

Phase 2/3

Not yet recruiting

Conditions: Other disorders of skin and subcutaneous tissue, not elsewhere classified,

Registration Number: CTRI/2021/08/035828

Lead Sponsor: DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CAREJNMCHAMUALIGARH

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients of burn injury of hands of 2weeks -12 weeks duration.
ASA I and II patients, of age varying from 15years to 60 years.
No h/o neurological or cognitive dysfunction.
Can perform hands movement without assistance.

Exclusion Criteria

Patients with amputated limb/phantom limb.
H/o susceptibility to motion sickness.
History of claustrophobia 4.
Patients reported a feeling of anxiety or discomfort while viewing 3D environment.
Patients with psychiatric illness and seizure disorders.
Burn to face/scalp which prevent use of HMD.
Deaf /visually challenged patients 8.
Acute infection.
Burn> 30% bodysurface surface area.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EFFECT OF VR ON PAIN INTENSITY IN PATIENTS OF BURN INJURY OF HANDS	4 WEEKS

Secondary Outcome Measures

Name	Time	Method
To explore the efficacy of virtual reality (VR) therapy on:	1. Requirements of analgesics on weekly basis.

Trial Locations

Locations (1): DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH
🇮🇳
Aligarh, UTTAR PRADESH, India
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH
🇮🇳Aligarh, UTTAR PRADESH, India
BALASUBRAMANIYAM C
Principal investigator
9600198005
likeablebala@gmail.com