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临床试验/NCT03467685
NCT03467685已完成不适用

Determining the Variable Factors in Cutaneous Perception of Vibratory Stimulation

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2018年6月19日最近更新:
适应症
干预措施

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

Placebo Comparator

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bryan Carroll

Assistant Professor

University of Pittsburgh

研究点 (1)

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