NCT06398847Recruiting
Virtual Reality (VR) Self-Hypnosis Software
An Open-label Study of Self-hypnosis Software for Virtual Reality for the Treatment of HIV-associated Chronic Pain - a Development and Usability Study
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 28 Mar 2024
- Start date
- 26 Mar 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- NCT number
- NCT06398847
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 26 Mar 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another investigational protocol for pain treatment
- Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological conditions contraindicating the use of virtual reality devices.
Other illness
- A co-occurring medical or psychiatric condition which would make participation in the study or complicate measurement of changes associated with the intervention.
- 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.
- A medical condition predisposing prospective participant to nausea or dizziness 6. Lack of stereoscopic vision or severe hearing impairment
Other
- 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
Who the study is looking for
- 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.
Criteria the registry did not label
- Patient Eligibility
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.