search
Back to results

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

Primary Purpose

Perioperative Pain, Perioperative Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Distraction
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative Pain focused on measuring Pain, Anxiety, Intraoperative Care

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UCSF Orthopedic InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Virtual Reality Intervention Group

Arm Description

Usual anesthetic care.

Virtual Reality Distraction

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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.
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.
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.

Secondary Outcome Measures

Blood Pressure
Systolic and diastolic blood pressure (mmHg)
Heart Rate
Beats per minute (bpm)
Satisfaction with Anesthesia Survey
An instrument that measures patient satisfaction with anesthesia care through open-ended and ranked response questions.
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.

Full Information

First Posted
May 24, 2018
Last Updated
July 13, 2022
Sponsor
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT03744845
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Pain, Perioperative Anxiety
Keywords
Pain, Anxiety, Intraoperative Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual anesthetic care.
Arm Title
Virtual Reality Intervention Group
Arm Type
Experimental
Arm Description
Virtual Reality Distraction
Intervention Type
Other
Intervention Name(s)
Virtual Reality Distraction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pre-Op Numeric Rating Scale for Pain
Description
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).
Time Frame
1 minute during pre-op period
Title
Pre-Op Numeric Rating Scale for Anxiety
Description
Self-reported anxiety intensity pre-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).
Time Frame
1 minute during pre-op period
Title
Post-Op Numeric Rating Scale for Pain
Description
Self-reported pain intensity post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).
Time Frame
1 minute during PACU stay
Title
Post-Op Numeric Rating Scale for Anxiety
Description
Self-reported anxiety intensity post-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).
Time Frame
1 minute during PACU stay
Title
Preoperative Medication Dosage
Description
The amount of midazolam (milligrams [mg]), opioids (mg or micrograms [mcg]), propofol (mg), and other sedatives administered to the patient prior to surgery.
Time Frame
up to 2 hours during pre-op period
Title
Intraoperative Medication Dosage
Description
The amount of midazolam (milligrams [mg]), opioid (mg or micrograms [mcg]), propofol (mg), and other sedatives (mg) administered to the patient during surgery.
Time Frame
up to 2 hours during surgery
Title
Postoperative Medication Dosage
Description
The amount of midazolam (milligrams [mg]), opioid (mg or micrograms [mcg]), propofol (mg), and other sedatives (mg) administered to the patient after surgery.
Time Frame
approximately 1 hour during PACU stay
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Systolic and diastolic blood pressure (mmHg)
Time Frame
up to 2 hours during surgery
Title
Heart Rate
Description
Beats per minute (bpm)
Time Frame
up to 2 hours during surgery
Title
Satisfaction with Anesthesia Survey
Description
An instrument that measures patient satisfaction with anesthesia care through open-ended and ranked response questions.
Time Frame
5 minutes during PACU stay
Title
Virtual Reality (VR) Survey
Description
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.
Time Frame
5 minutes during PACU stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sakura Kinjo, M.D.
Phone
415-514-4346
Email
Sakura.Kinjo@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Valeria Carcamo-Cavazos, M.D.
Email
Valeria.Carcamo-cavazos@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sakura Kinjo, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Orthopedic Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sakura Kinjo, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28475502
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.
Results Reference
background
PubMed Identifier
18325675
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.
Results Reference
background
PubMed Identifier
19955069
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.
Results Reference
background
PubMed Identifier
16640481
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.
Results Reference
background
PubMed Identifier
22864564
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.
Results Reference
background
PubMed Identifier
29049113
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.
Results Reference
background
PubMed Identifier
25678441
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.
Results Reference
background
PubMed Identifier
27400458
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 Jul 1;182(7):783.
Results Reference
background
PubMed Identifier
28598921
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.
Results Reference
background
PubMed Identifier
28794840
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs