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

September 26, 2022 updated by: University of California, Davis

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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)
Immediately before procedure and immediately after procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 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)
Immediately before procedure, during procedure, and immediately after procedure
Global Impression of Change
Time Frame: 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)
Immediately after procedure
Patient Experience Satisfaction
Time Frame: Immediately after procedure
Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)
Immediately after procedure
Sedation Requirements
Time Frame: During course of procedure
Amount of benzodiazepines and opioid medications given
During course of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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