Actively Recruiting
An Open-label Study of Self-hypnosis Software for Virtual Reality for the Treatment of HIV-associated Chronic Pain - a Development and Usability Study
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-04-02
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a self-hypnosis software delivered through a virtual reality (VR) headset to study its safety, usability, and potential for relieving chronic pain associated with HIV. This study focuses on adults living with HIV who experience musculoskeletal pain, neuropathic pain, or neuralgia. The research is supported by the Icahn School of Medicine at Mount Sinai through the i Prism Funding program. The study is conducted in two phases. The first phase involves software development and internal testing completed by April 15, 2024, without participant involvement. The second phase begins on May 20, 2024, enrolling participants into an open-label group to assess the feasibility and usability of the self-hypnosis VR software using an OculusGo device. Participants use the software and researchers monitor its use and any device-related side effects. Participants will be involved for about three weeks, during which the frequency of software use and any adverse events will be recorded. Quality of life related to pain is also assessed at weeks 2, 3, and 4 using specific pain scales. The study includes informed consent, regular assessments, and requires participants to have internet access and be able to comply with study procedures. Safety and usability are closely monitored throughout the study period.
CONDITIONS
Brief Title
Virtual Reality (VR) Self-Hypnosis Software
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 or older
- Confirmed diagnosis of HIV on stable antiretroviral treatment for at least 90 days
- Chronic pain related to HIV for at least 90 days
- Stable pain management or no pain treatments for at least 90 days
- Average pain intensity of 3 or greater on the numeric rating scale between visits
- Access to internet via smartphone, computer, or tablet
- Fluent in English
- Able to give informed consent and willing to follow study procedures
You will not qualify if you...
- Medical or psychiatric conditions that could interfere with participation or measurement
- Participation in another pain treatment investigational study
- Psychiatric disorder or life circumstance that could prevent study completion
- History of epilepsy, seizure disorder, dementia, migraines, or neurological conditions preventing VR use
- Medical conditions causing nausea or dizziness
- Lack of stereoscopic vision or severe hearing impairment
- Injury to eyes, face, or neck preventing VR headset use
- Use of personal VR devices during the study without agreement
- Currently pregnant or planning pregnancy during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or remote)
Duration - 21 days
Participants use the self-hypnosis software through a Virtual Reality headset to manage HIV-associated chronic pain and assess feasibility and usability.
Daily use of the VR software with monitoring
Duration - Approximately 2 weeks following implementation
Participants complete quality of life assessments at weeks 2, 3, and 4 to evaluate the impact of the VR software.
3 visits for assessments at Week 2, Week 3, and Week 4
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Mary Catherine George, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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