UC Davis Pain Clinic
Sacramento, California, 95817, United States
Location contact
Michael J. Jung, MD, MBA
CONTACT
Michael J. Jung, MD, MBA
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07779083
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Sacramento, California, 95817, United States
Michael J. Jung, MD, MBA
CONTACT
Michael J. Jung, MD, MBA
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: During the procedure, approximately 30 minutes
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
Whether opioid and/or sedative medications were administered during the prone pain procedure.
Time frame: During the procedure, approximately 30 minutes
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
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: Pre-procedure and post-procedure, approximately 30 minutes
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
State-Trait Anxiety Inventory 6-item (STAI-6). Scores range from 4 to 24. Higher scores indicate a worse outcome.
Time frame: Post-procedure, approximately 30 minutes
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. Scores range from 0 to 10. Higher scores indicate a better outcome.
Time frame: Post-procedure, approximately 30 minutes
Virtual Reality experience feedback (immersion, comfort, side effects, usability, task load). No score range or directionality as it is a free response section.
Contact information is provided by the study sponsor or research team.
University of California, Davis
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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