Virtual Reality (VR) for Prone Pain Procedures

Not Applicable

Completed

• Conditions: Pain; Virtual Reality; Anxiety
• Interventions: Other: Virtual Reality Headset

• Registration Number: NCT05615675
• Lead Sponsor: University of California, Davis

Brief Summary

The purpose of this study is to evaluate the effectiveness of virtual reality (VR) distraction in patients undergoing interventional pain procedures in the prone position. VR has been shown to improve patient experience during interventional pain procedures, however, many of these procedures are done in the prone position making VR a challenge. This study will evaluate the effect of a VR headset and support in patients undergoing prone interventional pain procedures compared to control.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-14
• Study Start: 2024-05-13
• Primary Completion: 2024-09-09
• Study Completion: 2024-09-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients aged 18 years old or older, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure
• English speaking and with the ability to understand oral and written instructions

Exclusion Criteria

• Pregnant women
• Prisoners
• Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality	Virtual Reality Headset	Patients undergo prone pain procedure with virtual reality distraction

Primary Outcome Measures

Name	Time	Method
Anxiety Score	Immediately after procedure	State-Trait Anxiety Inventory (Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety; Total range 20 to 80 with higher scores indicating greater anxiety).

Secondary Outcome Measures

Name	Time	Method
Global Impression of Change	Immediately after procedure	Global Impression of Change on a 7-point scale (Lower scores indicating decline in clinical status, and higher scores indicating improvement in clinical status)
Pain Score	Immediately before procedure, during procedure, and immediately after procedure	Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)
Anxiety Score	Immediately before procedure, during procedure, and immediately after procedure	Anxiety score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)
Patient Experience Satisfaction	Immediately after procedure	Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)
Sedation Requirements	During course of procedure	Amount of benzodiazepines and opioid medications given

Trial Locations

Locations (1)

UC Davis Interventional Pain Clinic; 🇺🇸 Sacramento, California, United States