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

NCT ID: NCT03744845

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2023-06-30

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.

Conditions

Perioperative Pain; Perioperative Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Usual anesthetic care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Virtual Reality Intervention Group

Virtual Reality Distraction

Group Type: EXPERIMENTAL

Virtual Reality Distraction

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sakura Kinjo, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Orthopedic Institute

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sakura Kinjo, M.D.

Role: CONTACT

Sakura.Kinjo@ucsf.edu

415-514-4346

Valeria Carcamo-Cavazos, M.D.

Role: CONTACT

Valeria.Carcamo-cavazos@ucsf.edu

Facility Contacts

Sakura Kinjo, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 28475502 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18325675 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19955069 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16640481 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22864564 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29049113 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25678441 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27400458 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28598921 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28794840 (View on PubMed)

Other Identifiers

17-22021

Identifier Type: -

Identifier Source: org_study_id