Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around
Principal Investigator
by Michael J. Jung, MD, MBA (ucdavis)

Description

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.

Keywords

Procedural Pain, Procedural Anxiety, Virtual Reality, Pain, Anxiety, Prone Pain Procedure, Audiovisual Distraction, Anxiety Disorders, Virtual Reality (VR) Audiovisual Distraction

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Pregnant women
  • Prisoners
  • Patients who have high risk of motion sickness
  • Seizure disorder
  • Visual/hearing impairment

Location

  • UC Davis Pain Clinic
    Sacramento California 95817 United States

Lead Scientist at University of California Health

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT07779083
Study Type
Interventional
Participants
Expecting 230 study participants
Last Updated