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This is a pilot feasibility and usability study of a virtual reality device for patients with chronic pain.
The investigators will conduct a study of patients with chronic pain to identify interest in participating in a large VR trial and, for those willing to join the team to test the device in person, to pilot 2 sessions of VR to assess usability and collect preliminary data on pain and mood and to obtain data on patient satisfaction with device use. Researchers expect the entire session to last 45 minutes to 1 hour.
All patients recruited will be in the active arm; this is not a randomized pilot study.
The intervention being piloted is the EaseVRx - AppliedVR, Los Angeles, CA - VR hardware and software. EaseVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. EaseVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. EaseVRx was designed for at-home use and comes with a sequence of daily immersive experiences, with each VR experience being 2-16 minutes in length (average of 6 minutes). For this pilot, researchers will be doing one in-person session, using two interoceptive VR experiences (out of 56 total).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EaseVRx sessions | Experimental | This is a study of patients with chronic pain to identify interest in participating in a large VR trial and, for those willing to join us to test the device in person, to pilot 2 sessions of VR to assess usability and collect preliminary data on pain and mood and to obtain data on patient satisfaction with device use. The entire session will last 45 minutes to 1 hour. All patients recruited will be in the active arm; this is not a randomized pilot study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EaseVRx | Device | Participants will experience 2 sessions of the EaseVRx device for chronic pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of participants contacted that are enrolled | We will determine feasibility by measuring the % of participants that are contacted who are enrolled. | at study 1 day visit |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with VR experience | We use the Global Impression of Change Scale, which is a 7 point Likert type scale, at the conclusion of the VR experience to measure patient's perceived impression of change before and after VR. | at study 1 day visit |
| Change in Mood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hector R Perez, MD, MS | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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We use the Brief Mood Introspection Scale, a 16-item scale, to measure change in mood before and after VR |
| at study 1 day visit |
| Change in Pain intensity | We use a 1-item pain intensity score (0-10) both before and after VR | at study 1 day visit |