Determining the Variable Factors in Cutaneous Perception of Vibratory Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Numeric Rating Score
研究概览
简要总结
Perception of cutaneous sensory stimulation shows a large range of variability across multiple populations. Understanding this variability is critical to medical practice as interpretation of discomfort and pain is critical to diagnosis and treatment. Further, procedural medicine involves inflicting pain on patients in the form of injection of local anesthetic. Our protocol aims to determine how patients differentially interpret the non-noxious stimulation of vibration and the differences in perceiving anesthestic injection after the vibratory stimulus. We will explore how this ranges across all patients treated in a dermatological surgery out-patient setting. The goal is to identify which variables, such as age, gender, medical history, influence how sensation is interpreted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Subjects will be asked to close their eyes prior to the vibration anesthetic device (VAD) being applied to their skin. Only the user will know whether the VAD will be on or off based on the result of a random number generator. This will prevent anticipatory changes on the subjects side. The subject will be aware of the intervention after the device is turned on or left in the off position.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients
排除标准
- •Patients less than 18 years of age
研究组 & 干预措施
VAD Off arm
This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration
干预措施: Vibratory Anesthetic Device (VAD) (Device)
VAD On arm
This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration
干预措施: Vibratory Anesthetic Device (VAD) (Device)
结局指标
主要结局
Numeric Rating Score
时间窗: Within 5 seconds of injection
This is a tool used to measure the degree of pain perceived by the patient with application of the tool on their skin and following the injection of anesthetic which is part of the routine medical care of the patient. Score ranges from 0 to 10 with higher score indicating more pain.
次要结局
未报告次要终点
研究者
Bryan Carroll
Assistant Professor
University of Pittsburgh
