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临床试验/NCT04513873
NCT04513873已完成不适用

The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy On Pain And Anxiety

Afyonkarahisar Health Sciences University2 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2019年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
256
试验地点
2
主要终点
Assessment of Children's Anxiety Level Change

研究概览

简要总结

This study aimed to investigate the effect of diverting the children's attention to a different point during phlebotomy which is an invasive procedure with acute pain. This is a randomized controlled experimental study. The study was conducted with two groups: the intervention group (n=127) and the control group (n=129). The control group was applied to standard phlebotomy procedures. In contrast, the intervention group had a piece of equipment that looks like a blood tube in front of them during the phlebotomy process to divert their attention from the phlebotomy process to the equipment.

详细描述

The equipment used for the intervention group was designed and developed by the researchers with the project support of TÜBİTAK BİDEB 2209A in 2016. It is an equipment that looks like a blood tube with a fixed arm on the right and a moving arm on the left with a total height of 80 cm. It has some answers to common questions of parents as well as the key concerns of the children " Will it hurt me?"

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
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • making a request for the phlebotomy
  • being in the 7-12 age group
  • having the consent of the parent
  • willing to participate in the research
  • with the history of invasive procedure
  • not using any medication with analgesic effect in the last 12 hours
  • without any communication barriers of either child or the parent
  • with a normal level of consciousness during the process
  • without the history of passing out during the phlebotomy

排除标准

  • not being in the 7-12 age group
  • not having the consent of the parent
  • not willing to participate in the research
  • without the history of invasive procedure
  • had medication with analgesic effect in the last 12 hours
  • with communication barriers of either child or the parent
  • with an abnormal level of consciousness during the process
  • with the history of passing out during the phlebotomy

结局指标

主要结局

Assessment of Children's Anxiety Level Change

时间窗: Twice ( Immediately after the procedure and 14 days after the procedure)

Children's Fear Scale is an instrument with five different face images changing from neutral (0= no fear) to most scared (4= with the most fear) to evaluate the scare level of the children during the procedure.

次要结局

  • Revised Face Pain Scale (FPS-R)(Twice ( During the procedure and 5-10 minutes after the procedure))

研究者

发起方
Afyonkarahisar Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeliz Ciğerci

Assistant Professor PhD

Afyonkarahisar Health Sciences University

研究点 (2)

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