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临床试验/NCT04714255
NCT04714255已完成不适用

The Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation

University of Witten/Herdecke2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年11月3日最近更新:
适应症

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
Self-reported pain

研究概览

简要总结

Peripheral Intravenous Cannulation (PIVC), one of the most common therapeutic procedures in medical care, can be difficult even for experienced medical practitioners. The pain of intravenous cannulation is considered the major limitation in pediatric clinical care. Reducing the pain of intravenous cannulation has been the motive for many investigations. Intervention methods used to reduce the distress related to painful procedures are widely recommended. The management of pain and anxiety is more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture-related pain and distress, with strong evidence supporting its efficacy in children.

Art therapy commonly used to reduce pain and anxiety of children's disease but was not used in reducing distress outcomes of painful procedures.

We used a collection of the image need for coloring and tracing called Trace Image and Coloring for Kids-Book (TICK-B).

The purpose of this study is to exam the effectiveness of TICK-B in decreasing pain and anxiety during cannulation.

详细描述

Peripheral Intravenous Cannulation (PIVC), one of the most common therapeutic procedures in medical care, can be difficult even for experienced medical practitioners. The pain of intravenous cannulation is considered the major limitation in pediatric clinical care. Reducing the pain of intravenous cannulation has been the motive for many investigations. Intervention methods used to reduce the distress related to painful procedures are widely recommended. The management of pain and anxiety is more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture-related pain and distress, with strong evidence supporting its efficacy in children.

Art therapy commonly used to reduce pain and anxiety of children's disease but was not used in reducing distress outcomes of painful procedures.

We used a collection of the image need for coloring and tracing called Trace Image and Coloring for Kids-Book (TICK-B).

The purpose of this study is to exam the effectiveness of TICK-B in decreasing pain and anxiety during cannulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients 6-12 years old,
  • Pediatric who needed peripheral cannulation,

排除标准

  • Children with chronic conditions,
  • impairments physical,
  • Disabilities with communicating difficulties,
  • Those whose parent not participated,
  • Neurodevelopmental delayed, can't verbal speak, hearing or visual impairments,
  • Children with coma or drowsiness,
  • have to take analgesic medication for less than 6 hrs.
  • history of syncope.

结局指标

主要结局

Self-reported pain

时间窗: Immediately after venipuncture (1-2 minutes after procedure, to mask , observer)

Pain: The severity of pain measured by Faces Pain Scale-Revised (FPS-R): The FPS-R ranking is a 0-10 scale with the six cartoons.

次要结局

  • Fear Measure(Time Frame: Immediately after venipuncture (1-2 min.))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherzad Khudeida Suleman

Principal Investigator (PhD Student)

University of Witten/Herdecke

研究点 (2)

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