Virtual-reality self-hypnosis for HIV-related chronic pain
An Open-label Study of Self-hypnosis Software for Virtual Reality for the Treatment of HIV-associated Chronic Pain - a Development and Usability Study
This trial will try a virtual-reality self-hypnosis program to see if it reduces chronic pain in adults living with HIV.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06398847 on ClinicalTrials.gov |
What this trial studies
The project uses an off-the-shelf VR headset (OculusGo) paired with self-hypnosis software developed by the study team to test safety, usability, and preliminary pain relief. Work is organized in two phases: Phase A involves software development and internal testing by the team, and Phase B enrolls participants to use the VR intervention. This single-site study at the Icahn School of Medicine at Mount Sinai received an FDA non-significant risk exemption. Participants will be adults with documented HIV-associated chronic pain on stable antiretroviral and pain regimens and will report baseline pain intensity of at least 3 on the numeric rating scale.
Who should consider this trial
Good fit: Adults (≥18) living with HIV who have had chronic HIV-associated pain for at least 90 days, are on a stable antiretroviral regimen and stable pain management for ≥90 days, report average pain ≥3, speak English, and can access the internet are ideal candidates.
Not a fit: Patients with unstable medical or psychiatric conditions, those currently in other investigational pain protocols, or those unable to tolerate or use VR technology are less likely to benefit.
Why it matters
Potential benefit: If successful, this could provide a non-drug, accessible tool to lessen HIV-associated chronic pain symptoms.
How similar studies have performed: Prior work shows VR and self-hypnosis can reduce pain in other chronic pain groups, but combining VR-delivered self-hypnosis specifically for HIV-related pain is relatively novel and has only preliminary data.
Eligibility criteria
Show full inclusion / exclusion criteria
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-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 6. 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
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Mary Catherine George, PhD
- Email: mary-catherine.george@mssm.edu
- Phone: 646-808-6231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.