Clinical trial NCT04163809: The Role of Virtual Reality During Regional Anesthesia
Official title: The Role of Virtual Reality During Regional Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Pain
Keywords: virtual reality
anxiety
pain
regional anesthesia
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety Level Prior to Regional Anesthesia
timeFrame: questionnaire given within 1 hour prior to regional anesthesia procedure
measure: Anxiety Level During Regional Anesthesia
timeFrame: questionnaire given within 1 hour after regional anesthesia procedure
measure: Pain Level Prior to Regional Anesthesia
timeFrame: questionnaire given within 1 hour prior to regional anesthesia procedure
measure: Pain Level During Regional Anesthesia
timeFrame: questionnaire given within 1 hour after regional anesthesia procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: CSMC Department of Anesthesiology
name: Mary Vijjeswarapu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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