| CTRI Number |
CTRI/2025/06/088596 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
08/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Virtual reality distraction] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare pain and anxiety that a patient might feel while undergoing a spine injection for chronic backache with and without virtual reality distraction |
|
Scientific Title of Study
|
Comparative evaluation of procedural pain and anxiety during interventional spine procedures with and without virtual reality distraction: a randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varun T S |
| Designation |
Junior Resident (Academic) |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care,
Room number 5011 teaching block
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9968856971 |
| Fax |
|
| Email |
varunts1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Pangasa |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care,
Room number 5011 teaching block
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9810383313 |
| Fax |
|
| Email |
nehapangasa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Pangasa |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care,
Room number 5011 teaching block
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9810383313 |
| Fax |
|
| Email |
nehapangasa@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
AIIMS, New Delhi-110029, India |
| 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 |
| Dr Varun T S |
AIIMS, New Delhi |
Pain clinic and pain operation theatre
Department of Anaesthesiology, Pain Medicine and Critical Care,
AIIMS, New Delhi - 110029
South
DELHI |
9968856971
varunts1993@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local anaesthetic |
Standard local anaesthetic infiltration |
| Intervention |
Virtual reality plus local anaesthetic |
Virtual reality distraction along with standard local anaesthetic infiltration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA status I to III, aged between 18 and 70 years, with chronic low back pain (LBP) rated 4 or more on Numerical Rating Scale (NRS), requiring interlaminar epidural steroid injection (ILESI), transforaminal epidural steroid injection (TFESI) or diagnostic medial branch block (MBB) according to the treating pain physician’s advice. |
|
| ExclusionCriteria |
| Details |
1)Refusal of consent
2)Visual or hearing impairment
3)Inability to lie prone
4)History of claustrophobia
5)Received steroid injection in the last 6 weeks
6)Local site infection
7)Allergic to contrast or local anaesthetic
8)Known bleeding disorders or coagulopathy
9)Use of antidepressants or antipsychotics
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Procedural pain assessed using NRS, a 0-10 scale (0 = no pain, 10 = worst pain imaginable)
|
Assessed immediately after shifting to post-anaesthesia care unit (PACU) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sympathetic response to painful stimulus (blood pressure and heart rate changes) |
Recorded at baseline and every 5 minutes during the procedure |
| Procedure-related anxiety assessed on a 1-5 Likert scale |
Assessed immediately after shifting to post-anaesthesia care unit (PACU) |
| Procedure satisfaction assessed on a 1-5 Likert scale |
Assessed immediately after shifting to post-anaesthesia care unit (PACU) |
| Time to discharge from PACU recorded in minutes |
Recorded at discharge |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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 4 |
|
Date of First Enrollment (India)
|
19/06/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [varunts1993@gmail.com].
- For how long will this data be available start date provided 16-06-2027 and end date provided 16-06-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NO
|
|
Brief Summary
|
Various studies support the use of virtual reality (VR) as an effective modality for alleviating pain and anxiety during interventional medical procedures. However, the role of VR in chronic pain interventions is less explored. No studies could be found in the Indian population on the effectiveness of VR for procedural pain and anxiety during interventional spine procedures. This study aims to address this lacuna in literature.
|