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

Perioperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03744845
• Other study ID #: 17-22021
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: University of California, San Francisco
• Contact: Sakura Kinjo, M.D.
• Phone: 415-514-4346
• Email: Sakura.Kinjo[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Perioperative Anxiety
• Perioperative Pain

Intervention

Other:
• Virtual 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.

Locations

Country	Name	City	State
United States	UCSF Orthopedic Institute	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (10)

Chan PY, Scharf S. Virtual Reality as an Adjunctive Nonpharmacological Sedative During Orthopedic Surgery Under Regional Anesthesia: A Pilot and Feasibility Study. Anesth Analg. 2017 Oct;125(4):1200-1202. doi: 10.1213/ANE.0000000000002169. — View Citation

Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16. — View Citation

Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. — View Citation

Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138. Review. — View Citation

Mavridou P, Dimitriou V, Manataki A, Arnaoutoglou E, Papadopoulos G. Patient's anxiety and fear of anesthesia: effect of gender, age, education, and previous experience of anesthesia. A survey of 400 patients. J Anesth. 2013 Feb;27(1):104-8. doi: 10.1007/s00540-012-1460-0. Epub 2012 Aug 3. — View Citation

Mott J, Bucolo S, Cuttle L, Mill J, Hilder M, Miller K, Kimble RM. The efficacy of an augmented virtual reality system to alleviate pain in children undergoing burns dressing changes: a randomised controlled trial. Burns. 2008 Sep;34(6):803-8. doi: 10.1016/j.burns.2007.10.010. Epub 2008 Mar 5. — View Citation

Pandya PG, Kim TE, Howard SK, Stary E, Leng JC, Hunter OO, Mariano ER. Virtual reality distraction decreases routine intravenous sedation and procedure-related pain during preoperative adductor canal catheter insertion: a retrospective study. Korean J Anesthesiol. 2017 Aug;70(4):439-445. doi: 10.4097/kjae.2017.70.4.439. Epub 2017 Mar 15. — View Citation

Soelberg CD, Brown RE Jr, Du Vivier D, Meyer JE, Ramachandran BK. The US Opioid Crisis: Current Federal and State Legal Issues. Anesth Analg. 2017 Nov;125(5):1675-1681. doi: 10.1213/ANE.0000000000002403. Review. — View Citation

Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298. Erratum in: JAMA Intern Med. 2016 Sep 1;176(9):1412. JAMA Intern Med. 2022 Jun 1;182(6):690. JAMA Intern Med. 2022 May 16;:. — View Citation

West NA, Severtson SG, Green JL, Dart RC. Trends in abuse and misuse of prescription opioids among older adults. Drug Alcohol Depend. 2015 Apr 1;149:117-21. doi: 10.1016/j.drugalcdep.2015.01.027. Epub 2015 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Blood Pressure	Systolic and diastolic blood pressure (mmHg)	up to 2 hours during surgery
Secondary	Heart Rate	Beats per minute (bpm)	up to 2 hours during surgery
Secondary	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
Secondary	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