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OpenTrials
Completed

NCT Number: NCT05078242

Virtual Reality - Chronic Pain At-Home Pilot Study

This is a short pilot 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 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.

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 7 sessions of the EaseVRx device for chronic pain.

Primary outcomes

  1. % of participants contacted that are enrolled

    Time frame: at study 1 day visit

    The investigators 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

    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.

  2. Change in Mood

    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

  3. Change in Pain Intensity

    Time frame: at study 1 day visit

    The investigators will 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2021
Registry last updated
Mar 21, 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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