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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Perioperative Pain, Perioperative Anxiety

Intervention / Treatment
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* Other: Virtual Reality Distraction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Usual anesthetic care. | |
| Experimental: Virtual Reality Intervention Group<br>Virtual Reality Distraction | Other: Virtual Reality Distraction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-Op Numeric Rating Scale for Pain | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Systolic and diastolic blood pressure (mmHg) | up to 2 hours during surgery | 
| Heart Rate | Beats per minute (bpm) | up to 2 hours during surgery | 
| Satisfaction with Anesthesia Survey | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Anxiety, Intraoperative Care