Virtual Reality - Chronic Pain At-Home Pilot Study

Sponsor

Albert Einstein College of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05078242

Collaborator

(none)

Enrollment

Location

Arm

13.5

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: EaseVRx	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Virtual Reality - Chronic Pain At-Home Pilot Study

Actual Study Start Date :

Nov 15, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: EaseVRx sessions 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 Participants will experience 7 sessions of the EaseVRx device for chronic pain.

Arm

Intervention/Treatment

Experimental: Experimental: EaseVRx sessions

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

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

Outcome Measures

Primary Outcome Measures

% of participants contacted that are enrolled [at study 1 day visit]
The investigators will determine feasibility by measuring the % of participants that are contacted who are enrolled.

Secondary Outcome Measures

Satisfaction with VR experience [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.
Change in Mood [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
Change in Pain Intensity [at study 1 day visit]
The investigators will use a 1-item pain intensity score (0-10) both before and after VR

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

Albert Einstein College of Medicine

Investigators

Principal Investigator: Hector Perez, MS, MD, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Albert Einstein College of Medicine

ClinicalTrials.gov Identifier:

NCT05078242

Other Study ID Numbers:

2021-13471

First Posted:

Oct 14, 2021

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Mar 2, 2022