Musculoskeletal PainNCT06398847
Virtual Reality (VR) Self-Hypnosis Software
A study testing Virtual Reality headset in people with Musculoskeletal Pain and Neuropathic Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain, Neuropathic Pain, Neuralgia
- What is being tested?
- Virtual Reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mary Catherine George, PhD, 646-808-6231, mary-catherine.george@mssm.edu
Shatabdi Joshi, MS, 212-241-9951, shatabdi.joshi@mssm.edu
About this study
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
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.
Read the 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.
- Conditions
- Musculoskeletal Pain, Neuropathic Pain, Neuralgia
- Being tested
- Virtual Reality headset
- Keywords
- HIV chronic pain, Self-hypnosis, virtual reality software, non-drug treatment for chronic pain
- Medical subject headings
- Musculoskeletal Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality headsetDevice
Also called OculusGo™
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: twenty one days
Secondary outcomes (2)
Quality of Life measured using Pain, Enjoyment and General Activity Scale (PEG)
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.
Measured: at Week 2, 3 and week 4
Quality of life measured using Short Form Brief Pain Inventory (SF-BPI) Scale
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.
Measured: at Week 2, 3 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start26 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a combination device of virtual software developed by the study team to be inserted into an off the shelf virtual reality headset.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Catherine George, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398847
- Sponsor's protocol ID
- STUDY-23-00989
- Other IDs
- GCO#21-1216
- Status last verified
- Jul 2026
- First submitted
- 28 Mar 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06398847
- Acronym / sponsor ID
- STUDY-23-00989
- Conditions
- Musculoskeletal Pain, Neuropathic Pain, Neuralgia
- Keywords
- HIV chronic pain, Self-hypnosis, virtual reality software, non-drug treatment for chronic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a combination device of virtual software developed by the study team to be inserted into an off the shelf virtual reality headset.
| Arm | Type | Receives |
|---|---|---|
| HIV-associated Chronic Pain Patients | Other | Device: Virtual Reality headsetThe participants will be enrolled into an open label arm to determine feasibility and useability of the combination device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality headsetAlso: OculusGo™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. | Device | HIV-associated Chronic Pain Patients |
Primary outcome
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.
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.
2 secondary outcomes
Quality of Life measured using Pain, Enjoyment and General Activity Scale (PEG)
Time frame: at Week 2, 3 and week 4
Quality of life measured using Short Form Brief Pain Inventory (SF-BPI) Scale
Time frame: at Week 2, 3 and week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality headset in people with Musculoskeletal Pain and Neuropathic Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Catherine George, PhD (646-808-6231, mary-catherine.george@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of times the software is used (time frame: twenty one days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.