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

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ClinicalTrials.gov Identifier: NCT03744845
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Perioperative Pain Perioperative Anxiety Other: Virtual Reality Distraction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Virtual Reality to Reduce Anxiety and Pain in Perioperative Settings
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Control group
Usual anesthetic care.
Experimental: Virtual Reality Intervention Group
Virtual Reality Distraction
Other: 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.




Primary Outcome Measures :
  1. Pre-Op Numeric Rating Scale for Pain [ Time Frame: 1 minute during pre-op period ]
    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).

  2. Pre-Op Numeric Rating Scale for Anxiety [ Time Frame: 1 minute during pre-op period ]
    Self-reported anxiety intensity pre-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).

  3. Post-Op Numeric Rating Scale for Pain [ Time Frame: 1 minute during PACU stay ]
    Self-reported pain intensity post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).

  4. Post-Op Numeric Rating Scale for Anxiety [ Time Frame: 1 minute during PACU stay ]
    Self-reported anxiety intensity post-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).

  5. Preoperative Medication Dosage [ Time Frame: up to 2 hours during pre-op period ]
    The amount of midazolam (milligrams [mg]), opioids (mg or micrograms [mcg]), propofol (mg), and other sedatives administered to the patient prior to surgery.

  6. Intraoperative Medication Dosage [ Time Frame: up to 2 hours during surgery ]
    The amount of midazolam (milligrams [mg]), opioid (mg or micrograms [mcg]), propofol (mg), and other sedatives (mg) administered to the patient during surgery.

  7. Postoperative Medication Dosage [ Time Frame: approximately 1 hour during PACU stay ]
    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 :
  1. Blood Pressure [ Time Frame: up to 2 hours during surgery ]
    Systolic and diastolic blood pressure (mmHg)

  2. Heart Rate [ Time Frame: up to 2 hours during surgery ]
    Beats per minute (bpm)

  3. Satisfaction with Anesthesia Survey [ Time Frame: 5 minutes during PACU stay ]
    An instrument that measures patient satisfaction with anesthesia care through open-ended and ranked response questions.

  4. Virtual Reality (VR) Survey [ Time Frame: 5 minutes during PACU stay ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744845


Contacts
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Contact: Sakura Kinjo, M.D. 415-514-4346 Sakura.Kinjo@ucsf.edu
Contact: Valeria Carcamo-Cavazos, M.D. Valeria.Carcamo-cavazos@ucsf.edu

Locations
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United States, California
UCSF Orthopedic Institute Recruiting
San Francisco, California, United States, 94158
Contact: Sakura Kinjo, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Sakura Kinjo, M.D. University of California, San Francisco

Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03744845     History of Changes
Other Study ID Numbers: 17-22021
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Pain
Anxiety
Intraoperative Care
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders