Montefiore Medical Center
The Bronx, New York, 10467, United States
NCT Number: NCT04923568
This is a pilot feasibility and usability study of a virtual reality device for patients with chronic pain.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
The Bronx, New York, 10467, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will experience 2 sessions of the EaseVRx device for chronic pain
Time frame: at study 1 day visit
We will determine feasibility by measuring the % of participants that are contacted who are enrolled.
Time frame: 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.
Time frame: 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
Time frame: at study 1 day visit
We use a 1-item pain intensity score (0-10) both before and after VR
Albert Einstein College of Medicine
Other
Virtual Reality and Chronic Pain Pilot Usability Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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