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Virtual Reality - Chronic Pain At-Home Pilot Study

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EaseVRx
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Inability to give informed consent
  2. Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines
  3. Medical condition predisposing to nausea or dizziness
  4. Hypersensitivity to flashing light or motion
  5. No stereoscopic vision or severe hearing impairment
  6. Injury to eyes, face, or neck that prevents use of VR headset
  7. Currently pregnant, by self-report

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: EaseVRx sessions

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Satisfaction with VR experience
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.
Change in Mood
The investigators will use the Brief Mood Introspection Scale, a 16-item scale, to measure change in mood before and after VR
Change in Pain Intensity
The investigators will use a 1-item pain intensity score (0-10) both before and after VR

Full Information

First Posted
October 12, 2021
Last Updated
March 20, 2023
Sponsor
Albert Einstein College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05078242
Brief Title
Virtual Reality - Chronic Pain At-Home Pilot Study
Official Title
Virtual Reality - Chronic Pain At-Home Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: EaseVRx sessions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EaseVRx
Intervention Description
Participants will experience 7 sessions of the EaseVRx device for chronic pain.
Primary Outcome Measure Information:
Title
% of participants contacted that are enrolled
Description
The investigators will determine feasibility by measuring the % of participants that are contacted who are enrolled.
Time Frame
at study 1 day visit
Secondary Outcome Measure Information:
Title
Satisfaction with VR experience
Description
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.
Time Frame
at study 1 day visit
Title
Change in Mood
Description
The investigators will use the Brief Mood Introspection Scale, a 16-item scale, to measure change in mood before and after VR
Time Frame
at study 1 day visit
Title
Change in Pain Intensity
Description
The investigators will use a 1-item pain intensity score (0-10) both before and after VR
Time Frame
at study 1 day visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector Perez, MS, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

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Virtual Reality - Chronic Pain At-Home Pilot Study

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