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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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.
UCSF Orthopedic Institute
San Francisco, California, United States
RECRUITINGPre-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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: approximately 1 hour during PACU stay
Blood Pressure
Systolic and diastolic blood pressure (mmHg)
Time frame: up to 2 hours during surgery
Heart Rate
Beats per minute (bpm)
Time frame: 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.
Time frame: 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.
Time frame: 5 minutes during PACU stay