Recruiting

Self-Hypnosis

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06398847

Conditions

Musculoskeletal Pain

Neuropathic Pain

Neuralgia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Reality headset

Study Details

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

Study ID

NCT06398847

Start date

Mar 26, 2026

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

other: HIV-associated Chronic Pain Patients

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

Interventions

Virtual Reality headset

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.

Primary outcome measure

  • Number of times the software is used [ Time Frame: twenty one days ]
  • Number of adverse events related to the device [ Time Frame: twenty one days ]

Central Contacts and Locations

Central contacts

Mary Catherine George, PhD

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

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Mary Catherine George, PhD

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

Shatabdi Joshi, MS

212-241-9951shatabdi.joshi@mssm.edu

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-07-27.