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Clinical Trials/NCT04163809
NCT04163809Not yet recruitingNot Applicable

The Role of Virtual Reality During Regional Anesthesia

Cedars-Sinai Medical Center1 site in 1 country80 target enrollmentStarted: January 1, 2027Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
80
Locations
1
Primary Endpoint
Anxiety Level Prior to Regional Anesthesia

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel assignment
Primary Purpose
Prevention
Masking
None (open label)

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Elective pre-operative patients at Cedars-Sinai Medical Center who are receiving regional anesthesia
  • Between ages 18-64
  • Patient must be able to provide informed consent

Exclusion Criteria

  • Patients under the age of 18 & above age 64
  • Visual impairment
  • Pregnant women
  • Diagnosis of epilepsy/seizures, dementia, and/or cognitive impairment

Arms & Interventions

Control Group (no VR)

No Intervention

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

Experimental Group (VR)

Experimental

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

Intervention: Virtual Reality with Oculus Go headset (Device)

Outcomes

Primary Outcomes

Anxiety Level Prior to Regional Anesthesia

Time Frame: questionnaire given within 1 hour prior to regional anesthesia procedure

questionnaire to rate anxiety on a scale of 0-10

Pain Level Prior to Regional Anesthesia

Time Frame: questionnaire given within 1 hour prior to regional anesthesia procedure

questionnaire to rate pain on a scale of 0-10

Anxiety Level During Regional Anesthesia

Time Frame: questionnaire given within 1 hour after regional anesthesia procedure

questionnaire to rate anxiety on a scale of 0-10

Pain Level During Regional Anesthesia

Time Frame: questionnaire given within 1 hour after regional anesthesia procedure

questionnaire to rate pain on a scale of 0-10

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal investigator
Principal Investigator

Mary Vijjeswarapu

Physician

Cedars-Sinai Medical Center

Study Sites (1)

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Identifiers

NCT ID
NCT04163809
Other Study IDs
Pro00055672

Dates

First Submitted
(6 years ago)
First Posted
(6 years ago)
Primary Completion
(next year)
Study Completion
(next year)
Last Verified
(5 months ago)
Last updated
(last month)

Regulatory & Sharing

FDA Regulated Drug
No
FDA Regulated Device
Yes
IPD Sharing Plan
No
Has Results
No

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