Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic

University of California, Davis1 site in 1 country99 target enrollmentAugust 7, 2020

ConditionsVirtual Reality Anxiety Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Virtual Reality
Sponsor: University of California, Davis
Enrollment: 99
Locations: 1
Primary Endpoint: Anxiety Score
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy of VR distraction on reducing anxiety patients undergoing interventional pain procedures compared to placebo/active placebo or a non VR option.

Registry

clinicaltrials.gov

Start Date

August 7, 2020

End Date

February 9, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of California, Davis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients aged over 18 years old, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure
•English speaking
•Having the ability to understand oral and written instructions
•Willing to fill out psychometric surveys.

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 before procedure and 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

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