An Open-label Study of Self-hypnosis Software for Virtual Reality for the Treatment of HIV-associated Chronic Pain - a Development and Usability Study
Icahn School of Medicine at Mount Sinai
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 7. Fluent in English * Capable of giving informed consent and willingness to comply with study procedures. Exclusion Criteria: * A co-occurr…
Interventions
- DeviceVirtual Reality headset
Self-hypnosis software in a Virtual Reality headset. This is the development of software that provides a self-hypnosis experience that can be inserted into any virtual reality device.
Location
- Icahn School of Medicine at Mount SinaiNew York, New York