Icahn School of Medicine at Mount Sinai
New York, 10029, United States
Location status: Recruiting
Location contact
'David Dorfman
SUB_INVESTIGATOR
Mary Catherine George, PhD
CONTACT
Shatabdi Joshi, MS
CONTACT
NCT Number: NCT06398847
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10029, United States
Location status: Recruiting
'David Dorfman
SUB_INVESTIGATOR
Mary Catherine George, PhD
CONTACT
Shatabdi Joshi, MS
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient Eligibility
Inclusion criteria
Exclusion criteria
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™
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.
Time frame: twenty one days
Safety will be measured by any adverse events related to the use of the software and the device.
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.
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.
Contact information is provided by the study sponsor or research team.
Icahn School of Medicine at Mount Sinai
Other
An Open-label Study of Self-hypnosis Software for Virtual Reality for the Treatment of HIV-associated Chronic Pain - a Development and Usability Study
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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