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

Comparative evaluation of procedural pain and anxiety during interventional spine procedures with and without virtual reality distraction: a randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088596

Enrollment

162

Registered

2025-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Virtual reality plus local anaesthetic: Virtual reality distraction along with standard local anaesthetic infiltration Control Intervention1: Local anaesthetic: Standard local anaesthet

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Procedural pain assessed using NRS, a 0-10 scale (0 = no pain, 10 = worst pain imaginable) Timepoint: Assessed immediately after shifting to post-anaesthesia care unit (PACU)	—

Secondary

Measure	Time frame
Sympathetic response to painful stimulus (blood pressure and heart rate changes)Timepoint: Recorded at baseline and every 5 minutes during the procedure;Procedure-related anxiety assessed on a 1-5 Likert scaleTimepoint: Assessed immediately after shifting to post-anaesthesia care unit (PACU);Procedure satisfaction assessed on a 1-5 Likert scaleTimepoint: Assessed immediately after shifting to post-anaesthesia care unit (PACU);Time to discharge from PACU recorded in minutesTimepoint: Recorded at discharge	—

Measure

Time frame

Sympathetic response to painful stimulus (blood pressure and heart rate changes)Timepoint: Recorded at baseline and every 5 minutes during the procedure;Procedure-related anxiety assessed on a 1-5 Likert scaleTimepoint: Assessed immediately after shifting to post-anaesthesia care unit (PACU);Procedure satisfaction assessed on a 1-5 Likert scaleTimepoint: Assessed immediately after shifting to post-anaesthesia care unit (PACU);Time to discharge from PACU recorded in minutesTimepoint: Recorded at discharge

—

Countries

India

Contacts

Public ContactDr Neha Pangasa

AIIMS, New Delhi

nehapangasa@gmail.com9810383313

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026