VR and Chronic Pain Pilot Usability Study

NCT04923568 | Completed

• 1 other identifier: 2021-13108
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• % of participants contacted that are enrolled

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

  at study 1 day visit

Secondary Outcomes (3)

• Satisfaction with VR experience

  at study 1 day visit

• Change in Mood

  at study 1 day visit

• Change in Pain intensity

  at study 1 day visit

Study Arms (1)

EaseVRx sessions

EXPERIMENTAL

This is a study of patients with chronic pain to identify interest in participating in a large VR trial and, for those willing to join us 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. The entire session will last 45 minutes to 1 hour. All patients recruited will be in the active arm; this is not a randomized pilot study.

Device: EaseVRx

Interventions

EaseVRx DEVICE

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

EaseVRx sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Chronic pain (using self-report) with pain intensity \>=4 and confirmed by ICD-10 codes in medical record
• Fluency in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hector R Perez, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 11, 2021
• Study Start: August 3, 2021
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)