Trials / Completed
CompletedNCT05078242
Virtual Reality - Chronic Pain At-Home Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Albert Einstein College of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EaseVRx | Participants will experience 7 sessions of the EaseVRx device for chronic pain. |
Timeline
- Start date
- 2021-11-15
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2021-10-14
- Last updated
- 2023-03-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05078242. Inclusion in this directory is not an endorsement.