The Impact of a Music Intervention on Pain and Anxiety Associated With Local Anesthesia Administration During Dermatologic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain: visual analog scale (VAS)
研究概览
简要总结
The goal of the study is to determine the effect of classical music on participants pain and anxiety associated with lidocaine administration during routine standard of care dermatologic procedures.
详细描述
The study is a randomized, unblinded, prospective, single center clinical trial. The purpose of the study is to determine the effect of a music intervention in reducing anxiety and pain from local anesthesia administration in subjects undergoing a routine, standard of care dermatologic procedure. The study population will consist of 100 adult subjects undergoing a dermatologic procedure on the head and neck. Subjects will be randomized 1:1 into either the placebo or music intervention group.
Individuals randomized into the placebo (P) group will undergo a set of standardized steps prior to local anesthesia injection. Other factors such as skin preparation technique, needle size, anesthesia temperature, use of unbuffered solution, needle angle and approximate depth of injection will remain standardized. Individuals randomized into the music intervention (MI) group will undergo the same set of standardized steps and then be played Frederic Chopin's piano sonatas through a headphone device prior to injection. After local anesthesia administration, subjects in both treatment arms will be asked to fill out a demographics, pain and anxiety questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects undergoing dermatologic procedures on the head and neck
- •Ages 18-89 years old
- •English speaking
- •Willingness and the ability to understand and provide informed consent
排除标准
- •Subjects who are allergic to lidocaine
- •History of bleeding tendency or coagulopathy
- •Pregnant or lactating
- •Active skin infection in the treatment area
- •Active cancer diagnosis
- •Unable to understand the protocol or give informed consent
- •Any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject
结局指标
主要结局
Pain: visual analog scale (VAS)
时间窗: Assessed one time immediately after dermatologic procedure is complete
Subjects will rate the pain using the visual analog scale (VAS), which is a 10 cm line ranging from "no pain" (far left) to "extremely painful" (far right) where patients mark their pain score with a vertical line
Anxiety
时间窗: Assessed one time immediately after dermatologic procedure is complete
Subjects will rate their anxiety using the short form of the state trait anxiety inventory (STAI), which asks participants 6 questions about their anxiety levels and asks them to rank their response from 1-4.
次要结局
未报告次要终点