Virtual Reality - Chronic Pain At-Home Pilot Study

Albert Einstein College of Medicine

Status: Completed

Conditions: Chronic Pain

Treatments: Device: EaseVRx

Study type: Interventional

Funder types: Other

Identifiers

NCT05078242

2021-13471

Details and patient eligibility

About

This is a short pilot 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 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.

Enrollment: 6 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: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Experimental: EaseVRx sessions

Experimental group

Description:

This is a study of patients with chronic pain to assess usability of a VR device at home. The main goals are 1) to collect data on feasibility of recruitment, 2) to collect data on daily adherence to therapy, and 3) to collect preliminary effectiveness data on pain and mood outcomes. There will be 7 sessions over one week, with each session lasting about 2-16 minutes. All patients recruited will be in the active arm; this is not a randomized pilot study.

Treatment:

Device: EaseVRx