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Clinical Trials/NCT03744845
NCT03744845
Unknown
Not Applicable

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

University of California, San Francisco1 site in 1 country56 target enrollmentDecember 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perioperative Pain
Sponsor
University of California, San Francisco
Enrollment
56
Locations
1
Primary Endpoint
Preoperative Medication Dosage
Last Updated
3 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2018
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

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).

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.

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.

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).

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).

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).

Secondary Outcomes

  • Satisfaction with Anesthesia Survey(5 minutes during PACU stay)
  • Blood Pressure(up to 2 hours during surgery)
  • Heart Rate(up to 2 hours during surgery)
  • Virtual Reality (VR) Survey(5 minutes during PACU stay)

Study Sites (1)

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