Virtual Reality (VR) Self-Hypnosis Software

Not Applicable

Not yet recruiting

• Conditions: Neuropathic Pain; Neuralgia; Musculoskeletal Pain
• Interventions: Device: Virtual Reality headset

• Registration Number: NCT06398847
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-21
• Study Start: 2025-04-10
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIV-associated Chronic Pain Patients	Virtual Reality headset	The participants will be enrolled into an open label arm to determine feasibility and useability of the combination device.

Primary Outcome Measures

Name	Time	Method
Number of times the software is used	twenty one days	Feasibility of self-hypnosis software using VR devices as measured by frequency of use. The device software will have an ability to determine the number of times each participant used the self-hypnosis software during the 21-day period.
Number of adverse events related to the device	twenty one days	Safety will be measured by any adverse events related to the use of the software and the device.

Secondary Outcome Measures

Name	Time	Method
Quality of Life measured using Pain, Enjoyment and General Activity Scale (PEG)	at Week 2, 3 and week 4	Participants perception of pain and quality of life will be measured using the Pain, Enjoyment and General Activity Scale (PEG). The PEG (pain, enjoyment, general activity) composite score will be used to assess pain intensity and interference. The PEG is a 3-item score with potential responses of 0 to 10 with 10 being the most severe pain. The 3 PEG items referring to the past week are: average pain, how pain interfered with enjoyment of life, how pain interfered with general activity To compute the PEG score, add the responses to the questions above, then divide by three to get a final score out of 10, full scale ranges 0 (no pain) to 10 (most severe pain), with higher scores indicate higher levels of pain.
Quality of life measured using Short Form Brief Pain Inventory (SF-BPI) Scale	at Week 2, 3 and week 4	Participants perception of pain and quality of life will be measured using the Short Form Brief Pain Inventory (SF-BPI) Scale. BPI-SF is a 9-item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. This is a 10-point scale with 0 being the best possible score, meaning "no pain", and 10 being the worst possible score, meaning "pain as bad as you can imagine", thus, higher scores indicate worse health outcomes.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States