Pain Procedures and Anxiolysis Via Distraction With Virtual Reality

Not Applicable

Completed

• Conditions: Pain; Virtual Reality; Anxiety
• Interventions: Device: Virtual Reality Headset Distraction

• Registration Number: NCT04437173
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-18
• Study Start: 2020-08-07
• Primary Completion: 2022-02-09
• Study Completion: 2022-02-09
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Arm	Virtual Reality Headset Distraction	Patients undergo interventional pain procedure with virtual reality distraction

Primary Outcome Measures

Name	Time	Method
Anxiety Score	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 Outcome Measures

Name	Time	Method
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)
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)
Sedation Requirements	During course of procedure	Amount of benzodiazepines and opioid medications given
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)

Trial Locations

Locations (1)

UC Davis Interventional Pain Clinic; 🇺🇸 Sacramento, California, United States