Virtual Reality (VR) Self-Hypnosis Software

NCT06398847 | Recruiting

• 2 other identifiers: STUDY-23-00989GCO#21-1216
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Neuropathic Pain; Neuralgia

Keywords

HIV chronic pain; Self-hypnosis; virtual reality software; non-drug treatment for chronic pain

Outcome Measures

Primary Outcomes (2)

• Number of times the software is used

  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.

  twenty one days

• Number of adverse events related to the device

  Safety will be measured by any adverse events related to the use of the software and the device.

  twenty one days

Secondary Outcomes (2)

• Quality of Life measured using Pain, Enjoyment and General Activity Scale (PEG)

  at Week 2, 3 and week 4

• Quality of life measured using Short Form Brief Pain Inventory (SF-BPI) Scale

  at Week 2, 3 and week 4

Study Arms (1)

HIV-associated Chronic Pain Patients

OTHER

The participants will be enrolled into an open label arm to determine feasibility and useability of the combination device.

Device: Virtual Reality headset

Interventions

Virtual Reality headset DEVICE

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.

Also known as: OculusGo™

HIV-associated Chronic Pain Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Pain; Neuralgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Mary Catherine George, PhD

CONTACT

646-808-6231; mary-catherine.george@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinical Research

Model Details: This is a combination device of virtual software developed by the study team to be inserted into an off the shelf virtual reality headset.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: May 3, 2024
• Study Start: March 26, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be determined).

Locations

US (1)