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临床试验/NCT04236674
NCT04236674Unknown不适用

Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction

Temple University2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2020年1月27日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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