| CTRI Number |
CTRI/2022/03/040930 [Registered on: 09/03/2022] Trial Registered Prospectively |
| Last Modified On: |
05/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Virtual reality therapy in modulating pain in patients of traumatic hand injury. |
|
Scientific Title of Study
|
Use of immersive virtual reality therapy as a part of multimodal approach in modulating pain in patients of traumatic hand injury. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARSHA GAUTAM |
| Designation |
Junior Resident |
| Affiliation |
JNMCH,AMU |
| Address |
Department of Anaesthesiology and Critical care
Jawaharlal Nehru Medical Collage, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9958557339 |
| Fax |
|
| Email |
harshagautam16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HAMMAD USMANI |
| Designation |
Professor |
| Affiliation |
JNMCH,AMU |
| Address |
Department of Anaesthesiology and Critical care
Jawaharlal Nehru Medical Collage, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897114190 |
| Fax |
|
| Email |
hammadusmani2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HARSHA GAUTAM |
| Designation |
Junior Resident |
| Affiliation |
JNMCH,AMU |
| Address |
Department of Anaesthesiology and Critical care
Jawaharlal Nehru Medical Collage, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9958557339 |
| Fax |
|
| Email |
harshagautam16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical care
Jawaharlal Nehru Medical Collage, Aligarh Muslim University |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical care |
| Address |
Department of Anaesthesiology and Critical care
Jawaharlal Nehru Medical Collage, Aligarh Muslim University |
| 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 |
| HARSHA GAUTAM |
Virtual Reality Room (Pain Clinic) |
Department of Anaesthesiology and Critical care
Jawaharlal Nehru Medical Collage, Aligarh Muslim University
Aligarh
UTTAR PRADESH |
9958557339
harshagautam16@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: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C
(Control group) |
To watch 3D play in laptop and immitate actions will be asked to rate NRS pain scale rating 0 to 10 before and after 3D play. |
| Intervention |
Group VR
(Immersive Reality Therapy) |
o Group VR will be asked to wear HMD and play 3D game in VR for 10 mins and will be asked NRS pain scale rating 0 to 10 before and after VR therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of traumatic injury of hands of 2weeks-12weeks duration.
2.ASA I and II patients, of age varying from 18 years to 60 years.
3. No h/o neurological or cognitive dysfunction.
4. Can perform hands movement without assistance. |
|
| ExclusionCriteria |
| Details |
1.H/O susceptibility to motion sickness.
2.History of claustrophobia.
3.Patients reported a feeling of anxiety or discomfort while viewing 3D environment.
4.Patients with psychiatric illness and seizure disorders.
5.Burn to face/scalp which prevent use of HMD.
6.Patient with burn injury of hand. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of VR on pain intensity in patients of traumatic hand injury. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To explore efficacy of virtual reality (VR) therapy on:
1.Patient satisfaction score
2.Improvemant of quality of life using SF-12 score.
3.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)
|
16/03/2022 |
| 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="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 subjective experience of the patient and pain has a strong psychological component1. The way in which pain perceived depends on many factors including fear,anxiety,depression,past experiences,memory,understanding of pain,cultural conditioning,the direction patient look/focus their attention and other psychological factors can unhelpfully increase how much pain patients experience during painful medical procedures123.Virtual Reality (VR) is a tool in treating pain in patients of burns,trauma,sports injury,blunt force trauma,dental pain,thermal pain,urological endoscopies. VR draws attention into the computer generated world,leaving less attention available to the process incoming pain signals.4. VR is particularly attention-grabbing distraction technique,and is designed to give users the illusion of going inside computer generated virtual environment.5 Virtual Reality hardware and software can be used to provide passive and immersive experience that reduces patient anxiety both injection of local anaesthetic and during surgical procedure.6 VR is perfect match for reducing acute pain while wearing VR goggles,interacting with virtual world.1
MATERIALS AND METHOD
Following approval by board of studies , Department of Anaesthesiology and Critical Care and Ethical committee of Jawaharlal Nehru medical collage,Aligarh Muslim University,Aligarh. A prospective ,randomised,single blind study will be conducted on 50 patients during year 2020-2022. All eligible patients will be identified and 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 traumatic hand injury.
SECONDARY OBJECTIVE
To explore the efficacy of Virtual Reality(VR) therapy on:
Patient satisfaction score. Improvement of quality of life using SF-12 Score. Adverse outcomes effects.
RESULT
Study will be started after few weeks.Above mentioned parameters will be recorded and compared. |