Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923568
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2021-06-08
Brief Title:
VR and Chronic Pain Pilot Usability Study
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
Virtual Reality and Chronic Pain Pilot Usability Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None