The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The level of pain and change in pain between each time point will be assessed using the Wong-Baker FACES scale with use of thermomechanical device delivering stimuli, without delivering stimuli, and with use of ethyl chloride skin refrigerant spray.
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of a thermomechanical device delivering vibration and cold stimuli in lowering pain during intramatricial nail injections
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
- •Men and women aged 18 years or older
- •Must understand and voluntarily sign an informed consent form
- •All patients undergoing intramatricial nail injections at the Weill Cornell Medicine (WCM) Department of Dermatology
- •Willingness to participate in the study
排除标准
- •Inability of the patient to provide written informed consent for any reason
- •Failure to have nail injection performed
- •Likely inability to comply with the study protocol or cooperate fully with the research team
研究组 & 干预措施
External thermomechanical device delivering stimuli
The thermomechanical device is placed on the digit proximally to the injection site with the ice wings frozen and the vibration mechanism switched on.
干预措施: External thermomechanical device delivering cold and vibration stimuli (Device)
External thermomechanical device without delivering stimuli
The thermomechanical device is placed on the digit proximally to the injection site with the ice wings at room temperature (unfrozen) and the vibration mechanism switched off.
干预措施: External thermomechanical device without delivering cold and vibration stimuli (Device)
Nail injection with ethyl chloride skin refrigerant spray
Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion
干预措施: Ethyl chloride skin refrigerant spray (Drug)
结局指标
主要结局
The level of pain and change in pain between each time point will be assessed using the Wong-Baker FACES scale with use of thermomechanical device delivering stimuli, without delivering stimuli, and with use of ethyl chloride skin refrigerant spray.
时间窗: prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction
Pain will be self-reported, using the Wong-Baker FACES (0-10, with 0 representing absence of pain and 10 unbearable pain). Participants will be questioned about their level of pain in their nail prior to treatment, immediately after the needle insertion, during infiltration, and 5 seconds after needle extraction
次要结局
- Number of participants with at least one adverse event(Patients will be followed for 3 days following their nail injection)