Virtual Reality and Chronic Pain Pilot Usability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- % of participants contacted that are enrolled
研究概览
简要总结
This is a pilot feasibility and usability study of a virtual reality device for patients with chronic pain.
详细描述
The investigators will conduct a study of patients with chronic pain to identify interest in participating in a large VR trial and, for those willing to join the team to test the device in person, to pilot 2 sessions of VR to assess usability and collect preliminary data on pain and mood and to obtain data on patient satisfaction with device use. Researchers expect the entire session to last 45 minutes to 1 hour.
All patients recruited will be in the active arm; this is not a randomized pilot study.
The intervention being piloted is the EaseVRx - AppliedVR, Los Angeles, CA - VR hardware and software. EaseVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. EaseVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. EaseVRx was designed for at-home use and comes with a sequence of daily immersive experiences, with each VR experience being 2-16 minutes in length (average of 6 minutes). For this pilot, researchers will be doing one in-person session, using two interoceptive VR experiences (out of 56 total).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Chronic pain (using self-report) with pain intensity >=4 and confirmed by ICD-10 codes in medical record
- •Fluency in English
排除标准
- •Inability to give informed consent
- •Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines
- •Medical condition predisposing to nausea or dizziness
- •Hypersensitivity to flashing light or motion
- •No stereoscopic vision or severe hearing impairment
- •Injury to eyes, face, or neck that prevents use of VR headset
- •Currently pregnant, by self-report
结局指标
主要结局
% of participants contacted that are enrolled
时间窗: at study 1 day visit
We will determine feasibility by measuring the % of participants that are contacted who are enrolled.
次要结局
- Satisfaction with VR experience(at study 1 day visit)
- Change in Mood(at study 1 day visit)
- Change in Pain intensity(at study 1 day visit)