Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06398847 | RECRUITING | Musculoskeletal Pain

Virtual Reality (VR) Self-Hypnosis Software
Sponsor:

Icahn School of Medicine at Mount Sinai

Information provided by (Responsible Party):

Mary Catherine George

Brief 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.

Condition or disease

Musculoskeletal Pain

Neuropathic Pain

Neuralgia

Intervention/treatment

Virtual Reality headset

Phase

NA

Detailed Description:

The study will be done in two phases - Phase A is the development of the software by the study team and the engineers targeted to be completed by 4/15/2024. Testing will occur with only the study team. No participants will be involved in the testing phase. Phase B is the participant enrollment phase targeted to start 5/20/2024. A request for FDA Exemption of a non-significant risk combination device has been submitted and granted.

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : NONE
Primary Purpose : DEVICE_FEASIBILITY
Official Title : An Open-label Study of Self-hypnosis Software for Virtual Reality for the Treatment of HIV-associated Chronic Pain - a Development and Usability Study
Actual Study Start Date : 2026-05-29
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • Virtual Reality (VR) Self-Hypnosis Software

    Location Details

    NCT06398847

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, New York

    Icahn School of Medicine at Mount Sinai

    New York, New York, United States, 10029