An interventional study of Virtual Reality (VR) Audiovisual Distraction in Procedural Pain and Procedural Anxiety, sponsored by University of California, Davis. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
Standard medical care based on the independent treating physician, which includes standard care such as numbing and sedating medicines without 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.
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.
Time frame: During the procedure, approximately 30 minutes
Opioid and Sedative Medication Use
Whether opioid and/or sedative medications were administered during the prone pain procedure.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-procedure, approximately 30 minutes
Patient Experience Satisfaction
Patient Experience Satisfaction. Scores range from 0 to 10. Higher scores indicate a better outcome.
Time frame: 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.
Time frame: Post-procedure, approximately 30 minutes
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of California, Davis