Pain Procedures and Anxiolysis Via Distraction With Virtual Reality (PAIN-VR)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Virtual Reality
• Intervention / Treatment: Device: Virtual Reality Headset Distraction

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Interventional Pain Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Arm; Patients undergo interventional pain procedure with virtual reality distraction	Device: Virtual Reality Headset Distraction; Patient wears a virtual reality headset during interventional pain procedure
No Intervention: No Intervention Arm; Patients undergo interventional pain procedure without virtual reality distraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Score	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)	Immediately before procedure and immediately after procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)	Immediately before procedure, during procedure, and immediately after procedure
Global Impression of Change	Global Impression of Change on a 7-point scale (Lower scores indicating decline in clinical status, and higher scores indicating improvement in clinical status)	Immediately after procedure
Patient Experience Satisfaction	Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)	Immediately after procedure
Sedation Requirements	Amount of benzodiazepines and opioid medications given	During course of procedure

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: John Sun, MD, University of California, Davis; Principal Investigator: Michael Jung, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Actual): February 9, 2022
• Study Completion (Actual): February 9, 2022

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 1480456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No