Virtual Reality - Chronic Pain At-Home Pilot Study

Chronic Pain Clinical Trial

Official title:

Virtual Reality - Chronic Pain At-Home Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05078242
• Other study ID #: 2021-13471
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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	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.	at study 1 day visit
Secondary	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	at study 1 day visit
Secondary	Change in Pain Intensity	The investigators will use a 1-item pain intensity score (0-10) both before and after VR	at study 1 day visit