Virtual Reality - Chronic Pain At-Home Pilot Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    10
  • sponsor
    Albert Einstein College of Medicine
Updated on 14 March 2022
chronic pain

Summary

This is a short pilot usability study of a virtual reality device for patients with chronic pain.

Description

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.

Details
Condition Chronic Pain
Treatment EaseVRx
Clinical Study IdentifierNCT05078242
SponsorAlbert Einstein College of Medicine
Last Modified on14 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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