Chronic Pain
Conditions
Brief summary
This is a short pilot usability study of a virtual reality device for patients with chronic pain.
Detailed description
The investigators will conduct a study of patients with chronic pain to collect feasibility of recruitment data, adherence to therapy data, and preliminary effectiveness data. All patients will be in the active arm, this is not a randomized 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. Each session will include one VR experience, which is 2-16 minutes in length (average of 6 minutes). This study will last one week, or 7 total sessions (out of 56 total sessions). Participants will complete one survey at 3 days over the telephone assessing pain, mood, adherence to the device, and overall satisfaction. Then participants will complete an additional assessment when the device is returned after day 7, again assessing pain, mood, overall adherence to the device, and overall satisfaction. The investigators are recruiting participants from the VR Usability Study (IRB # 2021-13108) who expressed interest in participating in further research. As this is a pilot feasibility trial, the plan is to recruit between 5 and 10 patients.
Interventions
DEVICEEaseVRx
Participants will experience 7 sessions of the EaseVRx device for chronic pain.
Sponsors
Albert Einstein College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Chronic pain (using self-report) with pain intensity \>=4 and confirmed by ICD-10 codes in medical record 3. Fluency in English
Exclusion criteria
1. Inability to give informed consent 2. Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines 3. Medical condition predisposing to nausea or dizziness 4. Hypersensitivity to flashing light or motion 5. No stereoscopic vision or severe hearing impairment 6. Injury to eyes, face, or neck that prevents use of VR headset 7. Currently pregnant, by self-report
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of participants contacted that are enrolled | at study 1 day visit | The investigators will determine feasibility by measuring the % of participants that are contacted who are enrolled. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with VR experience | at study 1 day visit | The investigators will 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. |
| Change in Mood | at study 1 day visit | The investigators will use the Brief Mood Introspection Scale, a 16-item scale, to measure change in mood before and after VR |
| Change in Pain Intensity | at study 1 day visit | The investigators will use a 1-item pain intensity score (0-10) both before and after VR |
Countries
United States
Outcome results
None listed