Virtual Reality - Chronic Pain At-Home Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 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 short pilot 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 collect feasibility of recruitment data, adherence to therapy data, and preliminary effectiveness data. All patients will be in the active arm, this is not a randomized 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. Each session will include one VR experience, which is 2-16 minutes in length (average of 6 minutes). This study will last one week, or 7 total sessions (out of 56 total sessions).
Participants will complete one survey at 3 days over the telephone assessing pain, mood, adherence to the device, and overall satisfaction. Then participants will complete an additional assessment when the device is returned after day 7, again assessing pain, mood, overall adherence to the device, and overall satisfaction.
The investigators are recruiting participants from the VR Usability Study (IRB # 2021-13108) who expressed interest in participating in further research. As this is a pilot feasibility trial, the plan is to recruit between 5 and 10 patients.
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 —（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
The investigators 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)