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NCT Number: NCT07779083

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Pain Clinic

Sacramento, California, 95817, United States

Location contact

Michael J. Jung, MD, MBA

CONTACT

[email protected]

916-734-6824

Michael J. Jung, MD, MBA

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality (VR) Audiovisual Distraction

Behavioral

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.

Primary outcomes

  1. Composite Outcome Using Win Ratio Method (Opioid/Sedative Use, Intra-procedural Pain Score, and Intra-procedural Anxiety Score)

    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.

Secondary outcomes

  1. Opioid and Sedative Medication Use

    Time frame: During the procedure, approximately 30 minutes

    Whether opioid and/or sedative medications were administered during the prone pain procedure.

  2. Intra-procedural Pain Score on the Numeric Rating Scale (NRS)

    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.

  3. Intra-procedural Anxiety Score on the Numeric Rating Scale (NRS)

    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.

  4. Pain Intensity on the Patient-Reported Outcomes Measurement Information System Pain Intensity Short Form-3a (PROMIS Pain Intensity SF-3a)

    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.

  5. Anxiety on the State-Trait Anxiety Inventory 6-item (STAI-6)

    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.

  6. Patient Global Impression of Change (PGIC)

    Time frame: Post-procedure, approximately 30 minutes

    Patient Global Impression of Change. Scores range from 1 to 7. Higher scores indicate a better outcome.

  7. Patient Experience Satisfaction

    Time frame: Post-procedure, approximately 30 minutes

    Patient Experience Satisfaction. Scores range from 0 to 10. Higher scores indicate a better outcome.

  8. Virtual Reality Experience Feedback

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael J. Jung, MD, MBA

CONTACT

[email protected]

916-734-6824

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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