- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04163809
The Role of Virtual Reality During Regional Anesthesia
August 12, 2026 updated by: Mary Vijjeswarapu, Cedars-Sinai Medical Center
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Janelle Burskey, RN
- Phone Number: 310-423-9600
- Email: janelle.burskey@cshs.org
Study Locations
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-
California
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
-
Contact:
- Janelle Burskey
- Phone Number: 310-423-9600
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
questionnaire given within 1 hour prior to regional anesthesia procedure
|
|
Anxiety Level During Regional Anesthesia
Time Frame: questionnaire given within 1 hour after regional anesthesia procedure
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questionnaire to rate anxiety on a scale of 0-10
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questionnaire given within 1 hour after regional anesthesia procedure
|
|
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
|
questionnaire given within 1 hour prior to regional anesthesia procedure
|
|
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
|
questionnaire given within 1 hour after regional anesthesia procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary Vijjeswarapu, MD, CSMC Department of Anesthesiology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
- Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.
- Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr. 2005 Mar 3;5(1):1. doi: 10.1186/1471-2431-5-1.
- McCaul KD, Malott JM. Distraction and coping with pain. Psychol Bull. 1984 May;95(3):516-33. No abstract available.
- Sharar SR, Alamdari A, Hoffer C, Hoffman HG, Jensen MP, Patterson DR. Circumplex Model of Affect: A Measure of Pleasure and Arousal During Virtual Reality Distraction Analgesia. Games Health J. 2016 Jun;5(3):197-202. doi: 10.1089/g4h.2015.0046. Epub 2016 May 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
November 3, 2019
First Submitted That Met QC Criteria
November 12, 2019
First Posted (Actual)
November 15, 2019
Study Record Updates
Last Update Posted (Actual)
August 14, 2026
Last Update Submitted That Met QC Criteria
August 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00055672
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.