VR and Chronic Pain Pilot Usability Study

Albert Einstein College of Medicine

Status: Completed

Conditions: Chronic Pain

Treatments: Device: EaseVRx

Study type: Interventional

Funder types: Other

Identifiers

NCT04923568

2021-13108

Details and patient eligibility

About

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

Full description

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).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

EaseVRx sessions

Experimental group

Description:

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.

Treatment:

Device: EaseVRx