Alopecia
Conditions
Brief summary
This study is prospective, single-site, randomized split-scalp pilot and survey study of patients at the NYU Skin and Cancer Clinic or the Faculty Group Practice. The investigators will randomize half of the scalp of each patient: one half will receive vibrational anesthesia (VA) via a device and the other half will not. Approximately 100 unique patients will be recruited (there will only be one study group). During the standard of care platelet rich plasma (PRP) procedure, a REDCap survey questionnaire will be provided asking the patients to rate their pain with the visual analogue scale (VAS). A simple paired t-test will be used to test significant improvement in pain scores between the two halves of the scalp.
Interventions
DEVICEVibrational Anesthesia (VA) Device
The half of the patient's scalp randomized to receive VA during PRP treatment will receive VA via the Buzzy bee-striped personal. The device is powered by two AAA batteries and is indicated for use for pain reduction. It uses the Melzack and Wall's Gait Control theory, which states that activation of non-nociceptive fibers can interfere with signals from pain fibers to inhibit overall sensation of pain.
PROCEDUREPRP Treatment
PRP (a needle-related procedure) will be delivered per routine standard of care.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have received at least one treatment of PRP to the scalp, which may include the PRP procedure performed day of. * Able to participate in study procedures. * Able to provide consent.
Exclusion criteria
* Patients missing the following data will be excluded from the final analysis: Patient age, gender, type of alopecia, PRP documentation. * Patients unable to consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Rating of Pain Perception at End of Procedure | End of procedure (About 10 minutes, Day 1) | At the end of the 10-minute PRP procedure, participants will rate their pain on: 1) The side of the scalp with no VA, and 2) the side of the scalp with VA. Participants will rate pain using a VAS, where pain is rated on a 0-10 scale; larger values indicate greater pain levels. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants who Opt to use VA among Participants in the "Control, then Intervention" Arm | Day 1 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKristen Lo Sicco
NYU Langone Health
Outcome results
None listed