A Pilot, Randomized, Non-blinded, Single-center Study of the Efficacy of a Vibrational Anesthesia (VA) Device on Reducing Pain During Platelet Rich Plasma (PRP) Scalp Treatment for Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Rating of Pain Perception at End of Procedure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients missing the following data will be excluded from the final analysis: Patient age, gender, type of alopecia, PRP documentation.
- •Patients unable to consent.
研究组 & 干预措施
Control (PRP Alone), then Intervention (PRP with VA)
Participants in this study arm will receive treatment with PRP alone first, then PRP+VA second. The first half of the scalp of each patient will be randomized to receive standard-of-care PRP alone. The second half of the scalp of each patient will receive VA via a device during the standard-of-care PRP treatment.
干预措施: Vibrational Anesthesia (VA) Device (Device)
Control (PRP Alone), then Intervention (PRP with VA)
Participants in this study arm will receive treatment with PRP alone first, then PRP+VA second. The first half of the scalp of each patient will be randomized to receive standard-of-care PRP alone. The second half of the scalp of each patient will receive VA via a device during the standard-of-care PRP treatment.
干预措施: PRP Treatment (Procedure)
Intervention (PRP with VA), then Control (PRP Alone)
Participants in this study arm will receive treatment with PRP+VA first, then PRP alone second. The first half of the scalp of each patient will be randomized to receive VA via a device during the standard-of-care PRP treatment.. The second half of the scalp of each patient will receive standard-of-care PRP treatment alone.
干预措施: Vibrational Anesthesia (VA) Device (Device)
Intervention (PRP with VA), then Control (PRP Alone)
Participants in this study arm will receive treatment with PRP+VA first, then PRP alone second. The first half of the scalp of each patient will be randomized to receive VA via a device during the standard-of-care PRP treatment.. The second half of the scalp of each patient will receive standard-of-care PRP treatment alone.
干预措施: PRP Treatment (Procedure)
结局指标
主要结局
Visual Analog Scale (VAS) Rating of Pain Perception at End of Procedure
时间窗: 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.
次要结局
- Percentage of Participants who Opt to use VA among Participants in the "Control, then Intervention" Arm(Day 1)