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NCT Number: NCT06398847

Virtual Reality (VR) Self-Hypnosis Software

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: OculusGo™

Primary outcomes

  1. Number of times the software is used

    Time frame: 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.

  2. Number of adverse events related to the device

    Time frame: twenty one days

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

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Catherine George, PhD

CONTACT

[email protected]

646-808-6231

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 3, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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