Procedural Anxiety, Procedural Pain
Conditions
Keywords
Virtual Reality, Pain, Anxiety, Prone Pain Procedure, Audiovisual Distraction
Brief summary
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.
Interventions
BEHAVIORALVirtual 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.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
N/A - The nature of the VR intervention (wearing a headset) prevents blinding of participants and care providers.
Intervention model description
Two-arm, parallel assignment, randomized controlled trial. Patients will be randomized in a 1:1 allocation to the intervention (VR headset with audiovisual calming nature scene and ergonomic cushion/support) vs control (standard medical care).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Outcome Using Win Ratio Method (Opioid/Sedative Use, Intra-procedural Pain Score, and Intra-procedural Anxiety Score) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid and Sedative Medication Use | During the procedure, approximately 30 minutes | Whether opioid and/or sedative medications were administered during the prone pain procedure. |
| Intra-procedural Pain Score on the Numeric Rating Scale (NRS) | 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. |
| Intra-procedural Anxiety Score on the Numeric Rating Scale (NRS) | 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. |
| Pain Intensity on the Patient-Reported Outcomes Measurement Information System Pain Intensity Short Form-3a (PROMIS Pain Intensity SF-3a) | 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. |
| Anxiety on the State-Trait Anxiety Inventory 6-item (STAI-6) | 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. |
| Patient Global Impression of Change (PGIC) | Post-procedure, approximately 30 minutes | Patient Global Impression of Change. Scores range from 1 to 7. Higher scores indicate a better outcome. |
| Patient Experience Satisfaction | Post-procedure, approximately 30 minutes | Patient Experience Satisfaction. Scores range from 0 to 10. Higher scores indicate a better outcome. |
| Virtual Reality Experience Feedback | 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. |
Countries
United States
Contacts
CONTACTMichael J. Jung, MD, MBA
PRINCIPAL_INVESTIGATORMichael J. Jung, MD, MBA
University of California, Davis
Outcome results
None listed