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

NCT03744845 | Unknown

• 1 other identifier: 17-22021
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Pain; Perioperative Anxiety

Keywords

Pain; Anxiety; Intraoperative Care

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Blood Pressure

  up to 2 hours during surgery

• Heart Rate

  up to 2 hours during surgery

• Satisfaction with Anesthesia Survey

  5 minutes during PACU stay

• Virtual Reality (VR) Survey

  5 minutes during PACU stay

Study Arms (2)

Control group

NO INTERVENTION

Usual anesthetic care.

Virtual Reality Intervention Group

EXPERIMENTAL

Virtual Reality Distraction

Other: Virtual Reality Distraction

Interventions

Virtual Reality Distraction OTHER

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.

Virtual Reality Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Orthopedic Institute

San Francisco, California, 94158, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 28475502 BACKGROUND

• 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.

  PMID: 18325675 BACKGROUND

• 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.

  PMID: 19955069 BACKGROUND

• 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.

  PMID: 16640481 BACKGROUND

• 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.

  PMID: 22864564 BACKGROUND

• 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.

  PMID: 29049113 BACKGROUND

• 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.

  PMID: 25678441 BACKGROUND

• 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.

  PMID: 27400458 BACKGROUND

• 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.

  PMID: 28598921 BACKGROUND

• 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.

  PMID: 28794840 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Sakura Kinjo, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sakura Kinjo, M.D.

CONTACT

415-514-4346; Sakura.Kinjo@ucsf.edu

Valeria Carcamo-Cavazos, M.D.

CONTACT

Valeria.Carcamo-cavazos@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: November 16, 2018
• Study Start: December 10, 2018
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)