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临床试验/NCT04163809
NCT04163809尚未招募不适用

The Role of Virtual Reality During Regional Anesthesia

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Pain Level Prior to Regional Anesthesia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Experimental Group (VR)

Experimental

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

干预措施: Virtual Reality with Oculus Go headset (Device)

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.

结局指标

主要结局

Pain Level Prior to Regional Anesthesia

时间窗: questionnaire given within 1 hour prior to regional anesthesia procedure

questionnaire to rate pain on a scale of 0-10

Anxiety Level Prior to Regional Anesthesia

时间窗: questionnaire given within 1 hour prior to regional anesthesia procedure

questionnaire to rate anxiety on a scale of 0-10

Anxiety Level During Regional Anesthesia

时间窗: questionnaire given within 1 hour after regional anesthesia procedure

questionnaire to rate anxiety on a scale of 0-10

Pain Level During Regional Anesthesia

时间窗: questionnaire given within 1 hour after regional anesthesia procedure

questionnaire to rate pain on a scale of 0-10

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Vijjeswarapu

Physician

Cedars-Sinai Medical Center

研究点 (1)

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