search
Back to results

VR and Chronic Pain Pilot Usability Study

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EaseVRx
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EaseVRx sessions

Arm 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.

Outcomes

Primary Outcome Measures

% of participants contacted that are enrolled
We will determine feasibility by measuring the % of participants that are contacted who are enrolled.

Secondary Outcome Measures

Satisfaction with VR experience
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
We use the Brief Mood Introspection Scale, a 16-item scale, to measure change in mood before and after VR
Change in Pain intensity
We use a 1-item pain intensity score (0-10) both before and after VR

Full Information

First Posted
June 8, 2021
Last Updated
September 27, 2023
Sponsor
Albert Einstein College of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT04923568
Brief Title
VR and Chronic Pain Pilot Usability Study
Official Title
Virtual Reality and Chronic Pain Pilot Usability Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
October 7, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EaseVRx sessions
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
EaseVRx
Intervention Description
Participants will experience 2 sessions of the EaseVRx device for chronic pain
Primary Outcome Measure Information:
Title
% of participants contacted that are enrolled
Description
We will determine feasibility by measuring the % of participants that are contacted who are enrolled.
Time Frame
at study 1 day visit
Secondary Outcome Measure Information:
Title
Satisfaction with VR experience
Description
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.
Time Frame
at study 1 day visit
Title
Change in Mood
Description
We use the Brief Mood Introspection Scale, a 16-item scale, to measure change in mood before and after VR
Time Frame
at study 1 day visit
Title
Change in Pain intensity
Description
We use a 1-item pain intensity score (0-10) both before and after VR
Time Frame
at study 1 day visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Chronic pain (using self-report) with pain intensity >=4 and confirmed by ICD-10 codes in medical record Fluency in English Exclusion Criteria: Inability to give informed consent Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines Medical condition predisposing to nausea or dizziness Hypersensitivity to flashing light or motion No stereoscopic vision or severe hearing impairment Injury to eyes, face, or neck that prevents use of VR headset Currently pregnant, by self-report
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector R Perez, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

VR and Chronic Pain Pilot Usability Study

We'll reach out to this number within 24 hrs