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Virtual Reality (VR) Audiovisual Distraction to Reduce Pain and Anxiety for Prone Pain Procedures

18 augusti 2026 uppdaterad av: Michael Jihnouk Jung, University of California, Davis
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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

230

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • California
      • Sacramento, California, Förenta staterna, 95817
        • UC Davis Pain Clinic
        • Kontakt:
        • Huvudutredare:
          • Michael J. Jung, MD, MBA

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Virtual Reality (VR) Audiovisual Distraction
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.
Beteende: Virtual 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.
Inget ingripande: Standard Care
Standard medical care based on the independent treating physician, which includes standard care such as numbing and sedating medicines without audiovisual distraction.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Composite Outcome Using Win Ratio Method (Opioid/Sedative Use, Intra-procedural Pain Score, and Intra-procedural Anxiety Score)
Tidsram: 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.
During the procedure, approximately 30 minutes

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Opioid and Sedative Medication Use
Tidsram: During the procedure, approximately 30 minutes
Whether opioid and/or sedative medications were administered during the prone pain procedure.
During the procedure, approximately 30 minutes
Intra-procedural Pain Score on the Numeric Rating Scale (NRS)
Tidsram: 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.
During the procedure, approximately 30 minutes
Intra-procedural Anxiety Score on the Numeric Rating Scale (NRS)
Tidsram: 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.
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)
Tidsram: 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.
Pre-procedure and post-procedure, approximately 30 minutes
Anxiety on the State-Trait Anxiety Inventory 6-item (STAI-6)
Tidsram: 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.
Pre-procedure and post-procedure, approximately 30 minutes
Patient Global Impression of Change (PGIC)
Tidsram: Post-procedure, approximately 30 minutes
Patient Global Impression of Change. Scores range from 1 to 7. Higher scores indicate a better outcome.
Post-procedure, approximately 30 minutes
Patient Experience Satisfaction
Tidsram: Post-procedure, approximately 30 minutes
Patient Experience Satisfaction. Scores range from 0 to 10. Higher scores indicate a better outcome.
Post-procedure, approximately 30 minutes
Virtual Reality Experience Feedback
Tidsram: 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.
Post-procedure, approximately 30 minutes

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of California, Davis

Utredare

  • Huvudutredare: Michael J. Jung, MD, MBA, University of California, Davis

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 december 2028

Avslutad studie (Beräknad)

1 december 2028

Studieregistreringsdatum

Först inskickad

18 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

18 augusti 2026

Första postat (Faktisk)

21 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2349412

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