VR and Chronic Pain Pilot Usability Study

NCT ID: NCT04923568

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-03
• Study Completion Date: 2022-10-07

Brief Summary

This is a pilot feasibility and 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 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).

Conditions

Chronic Pain

Study Design

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

Study Groups

EaseVRx sessions

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.

Group Type: EXPERIMENTAL

EaseVRx

Intervention Type: DEVICE

Participants will experience 2 sessions of the EaseVRx device for chronic pain

Interventions

EaseVRx

Participants will experience 2 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 R Perez, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

2021-13108

Identifier Type: -

Identifier Source: org_study_id