Virtual Reality (VR) Self-Hypnosis Software

Mount Sinai Health System

Status

Not yet enrolling

Conditions

Musculoskeletal Pain

Neuropathic Pain

Neuralgia

Treatments

Device: Virtual Reality headset

Study type

Interventional

Funder types

Other

Identifiers

NCT06398847

GCO#21-1216 (Other Grant/Funding Number)

STUDY-23-00989

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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