Virtual Reality (VR) Self-Hypnosis Software

Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398847
• Other study ID #: STUDY-23-00989
• Secondary ID: GCO#21-1216
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Mary Catherine George, PhD
• Phone: 646-808-6231
• Email: mary-catherine.george[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Pain
• Neuralgia
• Neuropathic Pain

Intervention

Device:
• Virtual Reality headset
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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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.	at Week 2, 3 and week 4
Secondary	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