Clinical trial NCT03744845: The Use of Virtual Reality to Reduce Anxiety and Pain in Perioperative Settings
Official title: The Use of Virtual Reality to Reduce Anxiety and Pain in Perioperative Settings
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perioperative Pain
Perioperative Anxiety
Keywords: Pain
Anxiety
Intraoperative Care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pre-Op Numeric Rating Scale for Pain
timeFrame: 1 minute during pre-op period
measure: Pre-Op Numeric Rating Scale for Anxiety
timeFrame: 1 minute during pre-op period
measure: Post-Op Numeric Rating Scale for Pain
timeFrame: 1 minute during PACU stay
measure: Post-Op Numeric Rating Scale for Anxiety
timeFrame: 1 minute during PACU stay
measure: Preoperative Medication Dosage
timeFrame: up to 2 hours during pre-op period
measure: Intraoperative Medication Dosage
timeFrame: up to 2 hours during surgery
measure: Postoperative Medication Dosage
timeFrame: approximately 1 hour during PACU stay
Secondary outcomes:
measure: Blood Pressure
timeFrame: up to 2 hours during surgery
measure: Heart Rate
timeFrame: up to 2 hours during surgery
measure: Satisfaction with Anesthesia Survey
timeFrame: 5 minutes during PACU stay
measure: Virtual Reality (VR) Survey
timeFrame: 5 minutes during PACU stay
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Orthopedic Institute
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sakura Kinjo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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. doi: 10.14219/jada.archive.2009.0102.
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. doi: 10.1089/cpb.2006.9.207.
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.
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.
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.
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.
citation: 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.
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.