NCT05078242

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

October 12, 2021

Last Update Submit

March 20, 2023

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • % of participants contacted that are enrolled

    The investigators 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)

Experimental: EaseVRx sessions

EXPERIMENTAL

This is a study of patients with chronic pain to assess usability of a VR device at home. The main goals are 1) to collect data on feasibility of recruitment, 2) to collect data on daily adherence to therapy, and 3) to collect preliminary effectiveness data on pain and mood outcomes. There will be 7 sessions over one week, with each session lasting about 2-16 minutes. All patients recruited will be in the active arm; this is not a randomized pilot study.

Device: EaseVRx

Interventions

EaseVRxDEVICE

Participants will experience 7 sessions of the EaseVRx device for chronic pain.

Experimental: EaseVRx sessions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hector Perez, MS, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 12, 2021

First Posted

October 14, 2021

Study Start

November 15, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations

US(1)