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Clinical Trials/NCT05615675
NCT05615675CompletedNot 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 enrollmentStarted: May 13, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Anxiety Score

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Virtual Reality

Experimental

Patients undergo prone pain procedure with virtual reality distraction

Intervention: Virtual Reality Headset (Other)

Control

No Intervention

Patients undergo prone pain procedure without virtual reality distraction

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).

Anxiety Score

Time Frame: 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).

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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