VR and Chronic Pain Pilot Usability Study

Chronic Pain Clinical Trial

Official title:

Virtual Reality and Chronic Pain Pilot Usability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04923568
• Other study ID #: 2021-13108
• Status: Completed
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: October 7, 2022

Study information

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

Clinical Trial Summary

This is a pilot feasibility and 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 identify interest in participating in a large VR trial and, for those willing to join the team 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. Researchers expect the entire session to last 45 minutes to 1 hour.

All patients recruited will be in the active arm; this is not a randomized pilot 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, with each VR experience being 2-16 minutes in length (average of 6 minutes). For this pilot, researchers will be doing one in-person session, using two interoceptive VR experiences (out of 56 total).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 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 2 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	We will determine feasibility by measuring the % of participants that are contacted who are enrolled.	at study 1 day visit
Secondary	Satisfaction with VR experience	We 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	We 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	We use a 1-item pain intensity score (0-10) both before and after VR	at study 1 day visit