Montefiore Medical Center
The Bronx, New York, 10467, United States
NCT Number: NCT05078242
This is a short pilot 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 collect feasibility of recruitment data, adherence to therapy data, and preliminary effectiveness data. All patients will be in the active arm, this is not a randomized 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. Each session will include one VR experience, which is 2-16 minutes in length (average of 6 minutes). This study will last one week, or 7 total sessions (out of 56 total sessions).
Participants will complete one survey at 3 days over the telephone assessing pain, mood, adherence to the device, and overall satisfaction. Then participants will complete an additional assessment when the device is returned after day 7, again assessing pain, mood, overall adherence to the device, and overall satisfaction.
The investigators are recruiting participants from the VR Usability Study (IRB # 2021-13108) who expressed interest in participating in further research. As this is a pilot feasibility trial, the plan is to recruit between 5 and 10 patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will experience 7 sessions of the EaseVRx device for chronic pain.
Time frame: at study 1 day visit
The investigators will determine feasibility by measuring the % of participants that are contacted who are enrolled.
Time frame: at study 1 day visit
The investigators will 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
The investigators will 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
The investigators will use a 1-item pain intensity score (0-10) both before and after VR
Albert Einstein College of Medicine
Other
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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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