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| ID | Type | Description | Link |
|---|---|---|---|
| GCO#21-1216 | Other Grant/Funding Number | i Prism Grant |
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This single-site study of self-hypnosis software using an off-the-shelf virtual reality (VR) device (OculusGoâ„¢) 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Patient Eligibility
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Catherine George, PhD | Contact | 646-808-6231 | mary-catherine.george@mssm.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
All of the individual participant data collected during the trial, after deidentification.
Beginning 9 months and ending 36 months following article publication.
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).
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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This is a combination device of virtual software developed by the study team to be inserted into an off the shelf virtual reality headset.
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| 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. | at Week 2, 3 and week 4 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |