VR and Chronic Pain Pilot Usability Study

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: EaseVRx

• Registration Number: NCT04923568
• Lead Sponsor: Albert Einstein College of Medicine

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).

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-11
• Study Start: 2021-08-03
• Primary Completion: 2022-10-07
• Study Completion: 2022-10-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EaseVRx sessions	EaseVRx	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.

Primary Outcome Measures

Name	Time	Method
% of participants contacted that are enrolled	at study 1 day visit	We will determine feasibility by measuring the % of participants that are contacted who are enrolled.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with VR experience	at study 1 day visit	We 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	We 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	We use a 1-item pain intensity score (0-10) both before and after VR

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States