The Use of Virtual Reality to Reduce Anxiety and Pain in Perioperative Settings

July 13, 2022 updated by: University of California, San Francisco
We will investigate whether the use of Virtual Reality (VR) preoperatively and intraoperatively can help treat pain and anxiety, as measured by patient feedback, vital signs trends, and the amounts of anesthetics, pain medications and anxiolytics used during surgical procedures. The VR intervention will be studied during short hand surgeries normally performed using local anesthesia and sedation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Virtual Reality (VR) is a powerful and inexpensive technology that has been effectively used in healthcare settings to treat anxiety and pain, with minimal side effects. In the last two decades, opioid abuse and deaths related to opioids have increased, and opioid naive patients are at increased risk of opioid abuse when opioids are used during their surgical procedures. In addition, anesthetics, anxiolytics and analgesics, namely opioids, have a myriad of side effects that worsen patient experience, and lead to complications and increased costs. There are limited studies on the use of VR in the perioperative setting. Our study is a randomized controlled trial to investigate the use of VR to treat anxiety and pain in perioperative settings. We will recruit 56 patients, 28 in the control group and 28 in the VR group, undergoing short (<2 hrs) hand or upper extremity surgeries under local anesthesia and monitored anesthesia care (MAC). The control group will receive standard anesthetic management and the VR group will be exposed to VR in the preoperative setting and during the surgical procedure, using the clinically validated AppliedVR software. The data collected will included satisfaction questionnaires and pain scores for anxiety/pain pre- and post- procedure, vital signs trends to assess sympathetic response during surgery, and amount of anesthetics used. We hypothesize that the VR group will show decreased anxiety and pain, increased satisfaction, and decreased use of anesthetics during the procedure.

Study Type

Interventional

Enrollment (Anticipated)

56

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 Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Orthopedic Institute
        • Contact:
          • Sakura Kinjo, MD

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years old or older and less or equal to 75 years old.
  2. ASA physical status I-II.
  3. English speaking.
  4. Undergoing elective surgery with local anesthetic with sedation.
  5. Surgical time less than 2 hours.

Exclusion Criteria:

  1. ASA physical status III or above.
  2. Allergy to fentanyl, midazolam or propofol.
  3. History of seizure, migraines.
  4. Chronic Pain Syndrome.
  5. Use of high dose opioids or long acting opioids.
  6. Severe anxiety, on daily anxiolytics.
  7. Psychiatric comorbidities that preclude the use of VR.
  8. Physical disabilities that preclude the use of VR technology in a comfortable manner.
  9. Patient refusal.

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
No Intervention: Control group
Usual anesthetic care.
Experimental: Virtual Reality Intervention Group
Virtual Reality Distraction
Other: Virtual Reality Distraction
This RCT will utilize an Oculus Go VR headset that delivers VR images and sound. Users will wear the VR headset. A research coordinator will familiarize patients with hardware before use. The VR will be used preoperatively and intraoperatively to distracts patients, and aid with the treatment of pain and anxiety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-Op Numeric Rating Scale for Pain
Time Frame: 1 minute during pre-op period
Self-reported pain intensity pre- and post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).
1 minute during pre-op period
Pre-Op Numeric Rating Scale for Anxiety
Time Frame: 1 minute during pre-op period
Self-reported anxiety intensity pre-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).
1 minute during pre-op period
Post-Op Numeric Rating Scale for Pain
Time Frame: 1 minute during PACU stay
Self-reported pain intensity post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).
1 minute during PACU stay
Post-Op Numeric Rating Scale for Anxiety
Time Frame: 1 minute during PACU stay
Self-reported anxiety intensity post-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).
1 minute during PACU stay
Preoperative Medication Dosage
Time Frame: up to 2 hours during pre-op period
The amount of midazolam (milligrams [mg]), opioids (mg or micrograms [mcg]), propofol (mg), and other sedatives administered to the patient prior to surgery.
up to 2 hours during pre-op period
Intraoperative Medication Dosage
Time Frame: up to 2 hours during surgery
The amount of midazolam (milligrams [mg]), opioid (mg or micrograms [mcg]), propofol (mg), and other sedatives (mg) administered to the patient during surgery.
up to 2 hours during surgery
Postoperative Medication Dosage
Time Frame: approximately 1 hour during PACU stay
The amount of midazolam (milligrams [mg]), opioid (mg or micrograms [mcg]), propofol (mg), and other sedatives (mg) administered to the patient after surgery.
approximately 1 hour during PACU stay

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: up to 2 hours during surgery
Systolic and diastolic blood pressure (mmHg)
up to 2 hours during surgery
Heart Rate
Time Frame: up to 2 hours during surgery
Beats per minute (bpm)
up to 2 hours during surgery
Satisfaction with Anesthesia Survey
Time Frame: 5 minutes during PACU stay
An instrument that measures patient satisfaction with anesthesia care through open-ended and ranked response questions.
5 minutes during PACU stay
Virtual Reality (VR) Survey
Time Frame: 5 minutes during PACU stay
An instrument designed by study staff to collect information on patients' experience wearing the VR device. The 16-question survey utilizes free-responses, yes/no, and ranked responses.
5 minutes during PACU stay

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Sakura Kinjo, M.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 10, 2018

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

May 24, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-22021

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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