The Role of Virtual Reality During Regional Anesthesia

Study Overview
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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.

Official Title
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The Role of Virtual Reality During Regional Anesthesia

Conditions
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Anxiety, Pain

Intervention / Treatment
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* Device: Virtual Reality with Oculus Go headset


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group (no VR)<br>Patients will be randomly allocated to the control group, which receives no Virtual Reality (VR) during the regional anesthesia procedure. | |
| Experimental: Experimental Group (VR)<br>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<br>* 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.<br>* Other names: Oculus Go;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Level Prior to Regional Anesthesia | 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 | questionnaire to rate anxiety on a scale of 0-10 | questionnaire given within 1 hour after regional anesthesia procedure | 
| Pain Level Prior to Regional Anesthesia | 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 | questionnaire to rate pain on a scale of 0-10 | questionnaire given within 1 hour after regional anesthesia procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, anxiety, pain, regional anesthesia