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
About this trial
This is an interventional treatment trial for Perioperative Pain focused on measuring Pain, Anxiety, Intraoperative Care
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.
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
NCT ID
NCT03744845
First Posted
May 24, 2018
Last Updated
July 13, 2022
Sponsor
University of California, San Francisco
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
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18325675
Citation
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Citation
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Citation
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Citation
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Results Reference
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The Use of Virtual Reality to Reduce Anxiety and Pain in Perioperative Settings
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