Perioperative Anxiety, Perioperative Pain
Conditions
Keywords
Pain, Anxiety, Intraoperative Care
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.
Interventions
OTHERVirtual 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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 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). |
| 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). |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSakura Kinjo, M.D.
University of California, San Francisco
Outcome results
None listed