Clinical trial NCT06398847: Virtual Reality (VR) Self-Hypnosis Software
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Musculoskeletal Pain
Neuropathic Pain
Neuralgia
Keywords: HIV chronic pain
Self-hypnosis
virtual reality software
non-drug treatment for chronic pain
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a combination device of virtual software developed by the study team to be inserted into an off the shelf virtual reality headset.
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of times the software is used
timeFrame: twenty one days
measure: Number of adverse events related to the device
timeFrame: twenty one days
Secondary outcomes:
measure: Quality of Life measured using Pain, Enjoyment and General Activity Scale (PEG)
timeFrame: at Week 2, 3 and week 4
measure: Quality of life measured using Short Form Brief Pain Inventory (SF-BPI) Scale
timeFrame: at Week 2, 3 and week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
References: