Virtual Reality - Chronic Pain At-Home Pilot Study

NCT ID: NCT05078242

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2022-12-31

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: EaseVRx sessions

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.

Group Type: EXPERIMENTAL

EaseVRx

Intervention Type: DEVICE

Participants will experience 7 sessions of the EaseVRx device for chronic pain.

Interventions

EaseVRx

Participants will experience 7 sessions of the EaseVRx device for chronic pain.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hector Perez, MS, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

2021-13471

Identifier Type: -

Identifier Source: org_study_id