An Open-label Study of Self-hypnosis Software for Virtual Reality for the Treatment of HIV-associated Chronic Pain - a Development and Usability Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of times the software is used
研究概览
简要总结
This single-site study of self-hypnosis software using an off-the-shelf virtual reality (VR) device (OculusGo™) to determine the software's safety, usability, and preliminary efficacy in pain relief for HIV-associated chronic pain patients. This is funded under the i Prism Funding through Mount Sinai Innovations.
详细描述
The study will be done in two phases - Phase A is the development of the software by the study team and the engineers targeted to be completed by 4/15/2024. Testing will occur with only the study team. No participants will be involved in the testing phase. Phase B is the participant enrollment phase targeted to start 5/20/2024. A request for FDA Exemption of a non-significant risk combination device has been submitted and granted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Patient Eligibility
- •Inclusion Criteria:
- •Adults age ≥18
- •Confirmed diagnosis of HIV, currently on a stable antiretroviral regimen ≥ 90 days.
- •Documentation of chronic pain associated with HIV for≥90 days
- •Stable pain management regimen ≥90 days, or no pain treatments ≥90 days
- •Average pain intensity of 3 or greater on the NRS of the mean daily scores reported between Visit 1 and Visit 2
- •Access to the internet via smartphone, computer, or tablet
- •Fluent in English
- •Capable of giving informed consent and willingness to comply with study procedures.
排除标准
- •A co-occurring medical or psychiatric condition which would make participation in the study or complicate measurement of changes associated with the intervention.
- •Concurrent participation in another investigational protocol for pain treatment
- •A psychiatric disorder, medical condition, or other life circumstance, which in the opinion of the PI, would contraindicate attendance at sessions, or make it unlikely that the participant could successfully complete the study procedures.
- •Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological conditions contraindicating the use of virtual reality devices.
- •A medical condition predisposing prospective participant to nausea or dizziness
- •Lack of stereoscopic vision or severe hearing impairment
- •Injury to eyes, face, or neck that impedes using the VR device
- •If participant has access to personal VR gear for gaming or other purposes at home, participant fails to agree not to use these personal VR gear during the course of the protocol.
- •Currently pregnant or planning to become pregnant during the study period
研究组 & 干预措施
HIV-associated Chronic Pain Patients
The participants will be enrolled into an open label arm to determine feasibility and useability of the combination device.
干预措施: Virtual Reality headset (Device)
结局指标
主要结局
Number of times the software is used
时间窗: twenty one days
Feasibility of self-hypnosis software using VR devices as measured by frequency of use. The device software will have an ability to determine the number of times each participant used the self-hypnosis software during the 21-day period.
Number of adverse events related to the device
时间窗: twenty one days
Safety will be measured by any adverse events related to the use of the software and the device.
次要结局
- Quality of Life measured using Pain, Enjoyment and General Activity Scale (PEG)(at Week 2, 3 and week 4)
- Quality of life measured using Short Form Brief Pain Inventory (SF-BPI) Scale(at Week 2, 3 and week 4)
研究者
Mary Catherine George
Director Clinical Research
Icahn School of Medicine at Mount Sinai