The Role of Virtual Reality During Regional Anesthesia

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04163809
Collaborator
(none)
80
1
2
28.1
2.8

Study Details

Study Description

Brief Summary

In this study, we will analyze the role of virtual reality in acute pain and anxiety management for regional anesthesia in pre-operative patients at Cedars-Sinai Medical Center.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality with Oculus Go headset
N/A

Detailed Description

Virtual reality (VR) is a technology that allows people to be immersed in an artificial 3D environment with visual and auditory stimulation. Recently, VR technology has been integrated into medical practices and used during multi-modal pain management. The purpose of this study is to analyze the role of VR in acute pain and anxiety management for regional anesthesia in pre-operative patients at Cedars-Sinai Medical Center (CSMC). Little is known about the role of virtual reality during regional anesthesia. Patients who volunteer to be apart of this study will be randomly assigned to one of two groups: one that receives VR (experimental group) and one that does not receive VR (control group) during the regional anesthesia procedure. Those who wear the Oculus Go virtual reality headset will view pleasant, distracting scenes. Patients that are included in the study must be between 18-64 years of age, pre-operative at CSMC, receiving regional anesthesia, and able to provide informed consent. No further follow up is required. Traditionally, pre-operative patients at CSMC do not have the option of wearing the VR apparatus during nerve block procedures, and some patients may receive pre-medications before nerve blocks. Those enrolled in the study will not receive pre-medication. Before and after the procedure, the patients will receive a brief questionnaire that will be used to determine if virtual reality can be an efficacious tool in reducing pain and anxiety during regional anesthesia. All data collection and storage will be at CSMC. If VR is found to have a statistically significant reduction of acute pain compared to the control group, we can offer VR to patients to help alleviate acute pain, discomfort, and anxiety during regional anesthesia procedures.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Role of Virtual Reality During Regional Anesthesia
Actual Study Start Date :
Jan 27, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group (no VR)

Patients will be randomly allocated to the control group, which receives no Virtual Reality (VR) during the regional anesthesia procedure.

Experimental: Experimental Group (VR)

Patients will be randomly allocated to the the experimental group, which receives VR during the regional anesthesia procedure.

Device: Virtual Reality with Oculus Go headset
The investigator will place the Oculus Go VR headset on the patient. VR will provide distracting, pleasant visual stimulus from the beginning of the procedure (while the patient is being cleaned and draped) and removed immediately after the regional anesthesia procedure is complete for roughly 10-20 minutes. All patients receiving VR will view the same scene.
Other Names:
  • Oculus Go
  • Outcome Measures

    Primary Outcome Measures

    1. Anxiety Level Prior to Regional Anesthesia [questionnaire given within 1 hour prior to regional anesthesia procedure]

      questionnaire to rate anxiety on a scale of 0-10

    2. Anxiety Level During Regional Anesthesia [questionnaire given within 1 hour after regional anesthesia procedure]

      questionnaire to rate anxiety on a scale of 0-10

    3. Pain Level Prior to Regional Anesthesia [questionnaire given within 1 hour prior to regional anesthesia procedure]

      questionnaire to rate pain on a scale of 0-10

    4. Pain Level During Regional Anesthesia [questionnaire given within 1 hour after regional anesthesia procedure]

      questionnaire to rate pain on a scale of 0-10

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Elective pre-operative patients at Cedars-Sinai Medical Center who are receiving regional anesthesia

    2. Between ages 18-64

    3. Patient must be able to provide informed consent

    Exclusion Criteria:
    1. Patients under the age of 18 & above age 64

    2. Visual impairment

    3. Pregnant women

    4. Diagnosis of epilepsy/seizures, dementia, and/or cognitive impairment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars Sinai Medical Center Los Angeles California United States 90048

    Sponsors and Collaborators

    • Cedars-Sinai Medical Center

    Investigators

    • Principal Investigator: Mary Vijjeswarapu, MD, CSMC Department of Anesthesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mary Vijjeswarapu, Physician, Cedars-Sinai Medical Center
    ClinicalTrials.gov Identifier:
    NCT04163809
    Other Study ID Numbers:
    • Pro00055672
    First Posted:
    Nov 15, 2019
    Last Update Posted:
    Dec 16, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Mary Vijjeswarapu, Physician, Cedars-Sinai Medical Center

    Study Results

    No Results Posted as of Dec 16, 2021