VR and Chronic Pain Pilot Usability Study

Study Overview
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Brief Summary
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This is a pilot feasibility and usability study of a virtual reality device for patients with chronic pain.

Detailed Description
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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).

Official Title
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Virtual Reality and Chronic Pain Pilot Usability Study

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: EaseVRx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Chronic pain (using self-report) with pain intensity >=4 and confirmed by ICD-10 codes in medical record Fluency in English Exclusion Criteria: Inability to give informed consent Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines Medical condition predisposing to nausea or dizziness Hypersensitivity to flashing light or motion No stereoscopic vision or severe hearing impairment Injury to eyes, face, or neck that prevents use of VR headset Currently pregnant, by self-report

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EaseVRx sessions<br>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. | Device: EaseVRx<br>* Participants will experience 2 sessions of the EaseVRx device for chronic pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |