Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Anxiety visual analog scale - pre-procedure
研究概览
简要总结
The study will prospectively analyze the analgesic and anxiolytic effects of thermomechanical stimulation (cold and vibration effects) with or without patient selected music preference during non-sedating interventional radiology procedures.
详细描述
There are wide ranging influences on the perception of human pain. The perception of pain is shaped by physiology, genetic factors, prior experiences, and external ameliorating factors. Extensive research has been performed in the pediatric population utilizing distraction as a means of reducing pain, particularly during venipuncture. These methods include medications (i.e. creams, anxiolytics), behavioral distraction (i.e. music, games), cold anesthesia, and thermomechanical stimulation via a cooling/vibrating device; however, fear and anxiety associated with needle procedures does not always resolve with time or age and can result in avoidance of treatment and delays in care. Few studies have focused on the impact of non-pharmacologic anxiolytics using thermomechanical stimulation and social anesthesia (i.e. music as a form of distraction) in the adult population. Utilizing non-pharmacologic measures is one of the first steps in procedural pain management. A thermomechanical device used in the pediatric population called Buzzy (MMJ Labs, Atlanta GA) employs a battery operated, handheld plastic device with a vibrating motor and a mechanism to attach an ice pack. This is used either independently or in combination. Most reports of the device demonstrate significant pain relief, but the majority of these completed studies focused on children undergoing venous cannulation. There have been a few cited uses in adult podiatry, dermatology, and pain management. In addition, passive music based intervention have been used in cancer patients undergoing biopsy and surgery, revealing a significant pain reduction effect. The study will prospectively analyze the analgesic and anxiolytic effects of thermomechanical stimulation (cold and vibration effects) with or without patient selected music preference during non-sedating interventional radiology procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-90 years of age
排除标准
- •prisoners, elderly, minors, pregnant women
结局指标
主要结局
Anxiety visual analog scale - pre-procedure
时间窗: Baseline (Prior to the procedure)
VAS pre-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety
Pain visual analog scale - post-procedure
时间窗: Immediately after the procedure
VAS post-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable
Anxiety visual analog scale - post-procedure
时间窗: Immediately after the procedure
VAS post-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety
Pain visual analog scale - pre-procedure
时间窗: Baseline (Prior to the procedure)
VAS pre-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable
次要结局
- Satisfaction survey(Immediately after the procedure)
