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临床试验/NCT06916468
NCT06916468已完成不适用

Improving Patient Comfort of Vibratory Anesthetic Devices With a Cotton Dampener

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2025年4月30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
53
试验地点
1
主要终点
Number of Participants Who Preferred the VAD With Cotton as Measured by Patient Report.

研究概览

简要总结

The study aims to determine the effectiveness of cotton as a dampener for vibratory anesthetic devices (VADs) for dermatologic patients. It will compare patient preferences for VAD use with and without cotton across different anatomical sites and identify factors, such as chronic pain or neuropathy status, that may influence these preferences. Finally, the study seeks to generate preliminary data to inform potential modifications to VAD use, optimizing patient comfort in dermatologic procedures

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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
是

入选标准

  • •Age range: from 18+
  • •Dermatologic patients at Westlake Clinic
  • •Consent: Must provide informed consent to participate in the study.
  • •Availability: Able to complete the entire study session, which includes testing all sites in a single session

排除标准

  • •Broken skin or known peripheral neuropathy on anatomical site of vibration.
  • •Allergies: Known allergy or sensitivity to nitrile gloves or cotton

研究组 & 干预措施

Cotton as a dampener for a standard vibratory anesthetic device

Experimental

A standard pen-like Vibratory Anesthetic Device (VAD) with and without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order. The study will be blinded to participants, who will be instructed to close their eyes or look away during the vibration application. After the pairs of VAD applications, patients will report their preference for each treatment condition.

干预措施: VAD with Cotton Dampener (Device)

Cotton as a dampener for a standard vibratory anesthetic device

Experimental

A standard pen-like Vibratory Anesthetic Device (VAD) with and without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order. The study will be blinded to participants, who will be instructed to close their eyes or look away during the vibration application. After the pairs of VAD applications, patients will report their preference for each treatment condition.

干预措施: Vibratory Anesthetic Device (VAD) (Device)

结局指标

主要结局

Number of Participants Who Preferred the VAD With Cotton as Measured by Patient Report.

时间窗: Up to 45 mins

Number of Participants Who Preferred the VAD Without Cotton as Measured Patient Report.

时间窗: Up to 45 mins

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

Physician

University Hospitals Cleveland Medical Center

研究点 (1)

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