Trials / Completed
CompletedNCT04416555
Virtual Reality Distraction for Reduction
Virtual Reality Distraction for Reduction in Acute Postoperative Pain
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- The Cleveland Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.
Detailed description
Specifically, the investigators propose to test the primary hypothesis that the use of AppliedVR software in Pico G2 4K headsets decreases acute postoperative pain scores (with a 1 point difference considered clinically important) compared to sham treatment on a 0-10 scale 15 minutes after each use in the first 48 hours after surgery or hospital discharge, whichever comes first.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Placebo comparator: VR googles and the non reality experience | parallel assignment (this arm will receive a static presentation in the same device) |
| DEVICE | Active Comparator: VR googles and the real VR program to enter act with and experience | Parallel assignment (this arm will receive the full immersive virtual reality experience |
Timeline
- Start date
- 2020-08-03
- Primary completion
- 2022-04-25
- Completion
- 2022-05-03
- First posted
- 2020-06-04
- Last updated
- 2023-11-27
- Results posted
- 2023-11-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04416555. Inclusion in this directory is not an endorsement.