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
About this trial
This is an interventional other trial for Chronic Pain
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
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
NCT ID
NCT04923568
First Posted
June 8, 2021
Last Updated
September 27, 2023
Sponsor
Albert Einstein College of Medicine
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
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VR and Chronic Pain Pilot Usability Study
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