Virtual Reality (VR) Audiovisual Distraction to Reduce Pain and Anxiety for Prone Pain Procedures

This study evaluates whether virtual reality (VR) audiovisual distraction can reduce pain, anxiety, and the need for pain and anxiety medications during prone pain procedures, compared to standard care alone. The trial design is a two-arm, parallel assignment, randomized controlled trial at a single site, the UC Davis Pain Medicine Clinic. Patients will be randomized in a 1:1 allocation to the intervention (commercially available virtual reality headset (Meta Quest 3) with audiovisual calming nature scene and an ergonomic cushion/support) vs control (standard medical care). The primary outcome will be a composite outcome analyzed using the Win Ratio method comparing opioid/sedative medication use, intra-procedural pain scores, and intra-procedural anxiety scores between groups. Approximately 230 people at UC Davis are expected to participate (Up to 20 patients for the preliminary run-in period to acclimatize research and clinical staff and 210 total for the randomized clinical trial). Each participant's involvement consists of one visit, estimated at 30 minutes.

Study Overview

• Status: Not yet recruiting
• Conditions: Procedural Pain; Procedural Anxiety
• Intervention / Treatment: Behavioral: Virtual Reality (VR) Audiovisual Distraction

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael J. Jung, MD, MBA; Phone Number: 916-734-6824; Email: mijjung@health.ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Pain Clinic
      • Contact: Michael J. Jung, MD, MBA; Phone Number: 916-734-6824; Email: mijjung@health.ucdavis.edu
      • Principal Investigator: Michael J. Jung, MD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 years old or older
• Male and female gender
• Referred to UC Davis Pain Medicine Clinic and require a prone 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
• 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 (VR) Audiovisual Distraction; Participants received a commercially available virtual reality headset (Meta Quest 3) with audiovisual calming nature scene and an ergonomic cushion/support in addition to standard medical care based on the independent treating physician.	Behavioral: Virtual Reality (VR) Audiovisual Distraction; Using a VR headset with an ergonomic cushion/support which will display a calming audiovisual experience during the procedure. The VR headset is a commercially available Meta Quest 3.
No Intervention: Standard Care; Standard medical care based on the independent treating physician, which includes standard care such as numbing and sedating medicines without audiovisual distraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Outcome Using Win Ratio Method (Opioid/Sedative Use, Intra-procedural Pain Score, and Intra-procedural Anxiety Score)	The primary outcome is a composite analyzed using the Win Ratio method. Each intervention patient will be compared with each control patient. Pairs are evaluated in priority order: opioid/sedative use, intra-procedural pain score, then intra-procedural anxiety score. A patient who received no opioids/sedatives wins over one who did; if tied, the lower pain score wins; if still tied, the lower anxiety score wins. If all three measures are identical, the pair is a tie. The Win Ratio is calculated as total intervention wins divided by total control wins. A Win Ratio >1 indicates superiority of VR; a 95% confidence interval will be calculated. Pain and anxiety are measured using the Numeric Rating Scale (NRS), from 0 (none) to 10 (worst possible), with higher scores indicating worse outcomes.	During the procedure, approximately 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid and Sedative Medication Use	Whether opioid and/or sedative medications were administered during the prone pain procedure.	During the procedure, approximately 30 minutes
Intra-procedural Pain Score on the Numeric Rating Scale (NRS)	Pain assessed using the Numeric Rating Scale (NRS). Scores range from 0 (no pain) to 10 (worst possible pain). Higher scores indicate a worse outcome.	During the procedure, approximately 30 minutes
Intra-procedural Anxiety Score on the Numeric Rating Scale (NRS)	Anxiety assessed using the Numeric Rating Scale (NRS). Scores range from 0 (no anxiety) to 10 (worst possible anxiety). Higher scores indicate a worse outcome.	During the procedure, approximately 30 minutes
Pain Intensity on the Patient-Reported Outcomes Measurement Information System Pain Intensity Short Form-3a (PROMIS Pain Intensity SF-3a)	PROMIS Pain Intensity Short Form-3a. Scores range from 3 to 15. Higher scores indicate a worse outcome.	Pre-procedure and post-procedure, approximately 30 minutes
Anxiety on the State-Trait Anxiety Inventory 6-item (STAI-6)	State-Trait Anxiety Inventory 6-item (STAI-6). Scores range from 4 to 24. Higher scores indicate a worse outcome.	Pre-procedure and post-procedure, approximately 30 minutes
Patient Global Impression of Change (PGIC)	Patient Global Impression of Change. Scores range from 1 to 7. Higher scores indicate a better outcome.	Post-procedure, approximately 30 minutes
Patient Experience Satisfaction	Patient Experience Satisfaction. Scores range from 0 to 10. Higher scores indicate a better outcome.	Post-procedure, approximately 30 minutes
Virtual Reality Experience Feedback	Virtual Reality experience feedback (immersion, comfort, side effects, usability, task load). No score range or directionality as it is a free response section.	Post-procedure, approximately 30 minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 18, 2026
• First Posted (Actual): August 21, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Virtual Reality; Audiovisual Distraction; Prone Pain Procedure
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Pain; Anxiety Disorders
• Other Study ID Numbers: 2349412

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No