Virtual Reality (VR) for Prone Pain Procedures

Immersive Audiovisual Distraction With Virtual Reality (VR) in Prone Procedures in the Interventional Pain Clinic

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Virtual Reality
• Intervention / Treatment: Other: Virtual Reality Headset

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Interventional Pain Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; Patients undergo prone pain procedure with virtual reality distraction	Other: Virtual Reality Headset; Patient uses a virtual reality headset and support during prone pain procedure; Other Names: Oculus Quest Virtual Reality Headset
No Intervention: Control; Patients undergo prone pain procedure without virtual reality distraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Score	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).	Immediately before procedure
Anxiety Score	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).	Immediately after procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Michael Jung, MD MBA, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Actual): September 9, 2024
• Study Completion (Actual): September 9, 2024

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1919687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No