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Clinical Trials/NCT05615675
NCT05615675
Completed
Not Applicable

Immersive Audiovisual Distraction With Virtual Reality (VR) in Prone Procedures in the Interventional Pain Clinic

University of California, Davis1 site in 1 country100 target enrollmentMay 13, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Virtual Reality
Sponsor
University of California, Davis
Enrollment
100
Locations
1
Primary Endpoint
Anxiety Score
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 13, 2024
End Date
September 9, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Anxiety Score

Time Frame: 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 Outcomes

  • Global Impression of Change(Immediately after procedure)
  • Pain Score(Immediately before procedure, during procedure, and immediately after procedure)
  • Anxiety Score(Immediately before procedure, during procedure, and immediately after procedure)
  • Patient Experience Satisfaction(Immediately after procedure)
  • Sedation Requirements(During course of procedure)

Study Sites (1)

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