Virtual Reality (VR) Self-Hypnosis Software
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Virtual Reality headset
DeviceSelf-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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: HIV-associated Chronic Pain PatientsOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
twenty one days2
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.
Time frame
twenty one daysSecondary outcomes
1
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.
Time frame
at Week 2, 3 and week 42
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.
Time frame
at Week 2, 3 and week 4Sponsors and contacts
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Source ClinicalTrials.gov