RecruitingNot ApplicableNCT06398847

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

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

25 participants

Start Date

Jan 31, 2026

Study Type

INTERVENTIONAL

Conditions

Musculoskeletal Pain Neuropathic Pain Neuralgia

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

Patient Eligibility
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 Criteria8

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

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.