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Virtual Reality (VR) for Prone Pain Procedures

Sponsor
University of California, Davis (Other)
Overall Status
Recruiting
CT.gov ID
NCT05615675
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of virtual reality (VR) distraction in patients undergoing interventional pain procedures in the prone position. VR has been shown to improve patient experience during interventional pain procedures, however, many of these procedures are done in the prone position making VR a challenge. This study will evaluate the effect of a VR headset and support in patients undergoing prone interventional pain procedures compared to control.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual Reality Headset
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Immersive Audiovisual Distraction With Virtual Reality (VR) in Prone Procedures in the Interventional Pain Clinic
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality

Patients undergo prone pain procedure with virtual reality distraction

Other: Virtual Reality Headset
Patient uses a virtual reality headset and support during prone pain procedure
Other Names:
  • Oculus Quest Virtual Reality Headset

    		•
    No Intervention: Control

    Patients undergo prone pain procedure without virtual reality distraction

    Outcome Measures

    Primary Outcome Measures

    1. Anxiety Score [Immediately before procedure]

      State-Trait Anxiety Inventory (Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety; Total range 20 to 80 with higher scores indicating greater anxiety).

    2. Anxiety Score [Immediately after procedure]

      State-Trait Anxiety Inventory (Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety; Total range 20 to 80 with higher scores indicating greater anxiety).

    Secondary Outcome Measures

    1. Anxiety Score [Immediately before procedure, during procedure, and immediately after procedure]

      Anxiety score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)

    2. Pain Score [Immediately before procedure, during procedure, and immediately after procedure]

      Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)

    3. Global Impression of Change [Immediately after procedure]

      Global Impression of Change on a 7-point scale (Lower scores indicating decline in clinical status, and higher scores indicating improvement in clinical status)

    4. Patient Experience Satisfaction [Immediately after procedure]

      Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)

    5. Sedation Requirements [During course of procedure]

      Amount of benzodiazepines and opioid medications given

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients aged 18 years old or older, who are referred to University of California Davis Pain Medicine Clinic and require an interventional 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, or visual/hearing impairment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC Davis Interventional Pain Clinic Sacramento California United States 95817

    Sponsors and Collaborators

    • University of California, Davis

    Investigators

    • Principal Investigator: Michael Jung, MD MBA, University of California, Davis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, Davis
    ClinicalTrials.gov Identifier:
    NCT05615675
    Other Study ID Numbers:
    • 1919687-1
    First Posted:
    Nov 14, 2022
    Last Update Posted:
    Nov 14, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 14, 2022