Virtual-reality self-hypnosis for HIV-related chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.