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

Phase 4

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2025/06/088596

Lead Sponsor: AIIMS, New Delhi

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 162

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): AIIMS, New Delhi
🇮🇳
South, DELHI, India
AIIMS, New Delhi
🇮🇳South, DELHI, India
Dr Varun T S
Principal investigator
9968856971
varunts1993@gmail.com