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

Not Applicable

• Conditions: Perioperative Pain; Perioperative Anxiety
• Interventions: Other: Virtual Reality Distraction

• Registration Number: NCT03744845
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-16
• Study Start: 2018-12-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Intervention Group	Virtual Reality Distraction	Virtual Reality Distraction

Primary Outcome Measures

Name	Time	Method
Pre-Op Numeric Rating Scale for Pain	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).
Preoperative Medication Dosage	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	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	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	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	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).
Post-Op Numeric Rating Scale for Anxiety	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 Outcome Measures

Name	Time	Method
Satisfaction with Anesthesia Survey	5 minutes during PACU stay	An instrument that measures patient satisfaction with anesthesia care through open-ended and ranked response questions.
Blood Pressure	up to 2 hours during surgery	Systolic and diastolic blood pressure (mmHg)
Heart Rate	up to 2 hours during surgery	Beats per minute (bpm)
Virtual Reality (VR) Survey	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.

Trial Locations

Locations (1)

UCSF Orthopedic Institute; 🇺🇸 San Francisco, California, United States