Effects of Virtual Reality on Pain and Anxiety Using Validated Surveys and Biodata Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Patient-reported Pain Level Pre Versus Post-VR Session
研究概览
简要总结
The purpose of this study is to assess the therapeutic response to VR Solace in patients with chronic pain and anxiety using real-time clinical and survey data. Regression analysis of demographic characteristics, lab and survey data will be conducted to better understand the efficacy of VR Solace in treating chronic pain and anxiety. The investigator also aims to explore the possible association between the patient-reported changes in pain or anxiety levels with real-time physiological changes observed during VR Solace use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endorsing pain/anxiety with objective measurement of 3 or greater on 10-point scale on validated survey
- •Diagnosis with chronic pain/anxiety
排除标准
- •Exclusion of patients that are followed by CL Psychiatry team at Cedars-Sinai Medical Center to avoid overlap with another ongoing VR study
- •No active diagnosis of medical conditions that may cause physiological variations in vital signs (i.e. sepsis, cardiogenic shock/arrhythmia)
- •No active diagnosis of seizures, migraines, severe nausea, severe propensity for motion sickness, or facial/head deformities that would allow for comfortable placement of headset
- •Exclusions of patient currently taking beta blockers
- •Unable to communicate/read English for survey items
- •Unable to use VR independently - patients will be expected to maneuver through questions/steps of the VR system during the session
结局指标
主要结局
Patient-reported Pain Level Pre Versus Post-VR Session
时间窗: Just prior to session to 15-minutes post session
Pain level pre- versus post-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).
Patient-reported Anxiety Level Pre Versus Post-VR Session
时间窗: Just prior to VR session and 15 minutes after the VR session
Anxiety level pre versus post-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale, 1 to 4, for each question, e.g. from "Almost Never" to "Almost Always". The scores are added up to produce a total score of anxiety. Higher scores indicate greater anxiety). Scores range from 20 to 80, with higher scores reflecting increased anxiety.
次要结局
未报告次要终点
研究者
Omer Liran
Assistant Professor, Department of Psychiatry & Behavioral Neurosciences
Cedars-Sinai Medical Center