The Role of Virtual Reality During Regional Anesthesia

NCT ID: NCT04163809

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-27

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Anxiety Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group (no VR)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Group (VR)

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

Group Type EXPERIMENTAL

Virtual Reality with Oculus Go headset

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Oculus Go

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Mary Vijjeswarapu

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Vijjeswarapu, MD

Role: PRINCIPAL_INVESTIGATOR

CSMC Department of Anesthesiology

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Janelle Burskey, RN

Role: CONTACT

310-423-9600

Facility Contacts

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Janelle Burskey

Role: primary

310-423-9600

References

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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.

Reference Type BACKGROUND
PMID: 5320816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15745448 (View on PubMed)

McCaul KD, Malott JM. Distraction and coping with pain. Psychol Bull. 1984 May;95(3):516-33. No abstract available.

Reference Type BACKGROUND
PMID: 6399756 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27171578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21779307 (View on PubMed)

Other Identifiers

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Pro00055672

Identifier Type: -

Identifier Source: org_study_id

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