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OpenTrials
Completed

NCT Number: NCT04923568

VR and Chronic Pain Pilot Usability Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EaseVRx

Device

Participants will experience 2 sessions of the EaseVRx device for chronic pain

Primary outcomes

  1. % of participants contacted that are enrolled

    Time frame: at study 1 day visit

    We will determine feasibility by measuring the % of participants that are contacted who are enrolled.

Secondary outcomes

  1. Satisfaction with VR experience

    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.

  2. Change in Mood

    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

  3. Change in Pain intensity

    Time frame: at study 1 day visit

    We use a 1-item pain intensity score (0-10) both before and after VR

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Registry information

Official study title

Virtual Reality and Chronic Pain Pilot Usability Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2021
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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