Pain
Conditions
Brief summary
The purpose of this research study is to explore the impact of virtual reality (VR) on pain perception during out-patient procedures such as wart removal, wound debridement, and lidocaine injections.
Interventions
OTHEROculus Go Virtual Reality System
The VR system will provide a 3D environment that provides distracting stimulus. Participant will put on the Oculus Go VR system headset 1-2 minutes prior to out-patient bedside procedure up to the completion of procedure which takes typically 3-5 minutes.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients 13 years and older. * Patient (or health care proxy when applicable) must sign an ICF. * Patient requiring any painful dermatological bedside procedure including: wound debridement, injections and liquid nitrogen application. * Patients willing to participate and parents able to consent.
Exclusion criteria
* Subjects with a diagnosis of vertigo, inner ear diseases or seizures are excluded due to the uncertainty of performance under VR conditions. * Subjects requiring procedures on the head are also excluded to the interference of the VR headset.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in average pain as assessed by the visual analog scale (VAS) | Baseline, up to 2 hours | VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain. |
| Change in maximum pain level as assessed by VAS | Baseline, up to 2 hours | VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate | Baseline, up to 2 hours | Heart rate will be assessed in beats per minute. |
| Change in oxygen saturation | Baseline, up to 2 hours | Oxygen saturation will be assessed as a percentage. |
| Incidence of intervention related adverse events | Baseline, up to 2 hours | Intervention related adverse events will be assessed per treating physician discretion. |
Countries
United States
Outcome results
None listed