RECRUITING

Virtual Reality (VR) Self-Hypnosis Software

Conditions

Musculoskeletal Pain Neuropathic Pain Neuralgia HIV chronic pain Self-hypnosis virtual reality software non-drug treatment for chronic pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-09-15

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06398847

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Mary Catherine George, PhD

CONTACT

646-808-6231

mary-catherine.george@mssm.edu

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-15

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2025-09-15

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Musculoskeletal Pain
Neuropathic Pain
Neuralgia