MedTrace Logo

Evaluating Vibrational Anesthesia in Scalp Platelet Rich Plasma (PRP)

NCT06497764 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Vibrational 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.

PROCEDURE

PRP Treatment

PRP (a needle-related procedure) will be delivered per routine standard of care.

Sponsors & Collaborators

Principal Investigators

  • Kristen Lo Sicco · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-07-01
Completion
2025-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06497764 on ClinicalTrials.gov