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临床试验/NCT05448508
NCT05448508已完成不适用

The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection

Ataturk University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月1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
60
试验地点
2
主要终点
Crying time in second

研究概览

简要总结

Heel blood sampling is a routine but painful procedure for newborns. A limited number of international studies have shown that automatic lancets are more effective with less pain and tissue damage than manual lancets.

In line with this information, this study was planned to investigate the effects of manual and automatic lancets on pain and stress in newborn capillary heel blood collection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
0 Days 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • Postnatal age zero day
  • Term newborn
  • No congenital anomalies
  • No advanced medical intervention at birth
  • Infants not receiving oxygen or respiratory support

排除标准

  • Legal guardian not giving consent to research

结局指标

主要结局

Crying time in second

时间窗: 12 week

The neo pain assessment scale

时间窗: 12 week

The neo scale was developed (2014) to assess pain and stress in premature and mature neonates. The Neo is a five-item scale including facial expression, breathing pattern, tone of extremities, hand and foot activity, and level of activity. The lowest and the highest scores obtainable from the scale are 0 and 10, respectively. As the score increases, stress and pain increase.

次要结局

未报告次要终点

研究者

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

Türkan Kadiroğlu

Director

Ataturk University

研究点 (2)

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