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临床试验/NCT04560374
NCT04560374已完成不适用

The Effect of Using Crochet Octopus in Reducing The Pain Developed During The Process of Heel Lance İn Neonates: A Randomized Controlled Study

Marmara University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5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
100
试验地点
1
主要终点
Neonate Infant Pain Scale Score

研究概览

简要总结

The main objective of the study was to determine the effect of using crochet octopus in order to reduce the acute pain developed during the process of heel lance in neonates.

The hypothesis of the study was "Crochet octopus is rather effective in reducing the acute pain in heel lance process for neonates".

详细描述

The study was conducted as randomized controlled. It included term neonates born between May 2020 and August 2020 at a training and research hospital. The study was completed with 100 neonates in total as 50 for experiment and 50 for control groups. During the process of heel lance, experiment group neonates were delivered crochet octopus 10 minutes before the process and let them touch the octopus 10 minutes more after the process. Control group neonates experienced the process without any intervention. As for the data collection, "Newborn Identification Form", "Neonatal-Infant Pain Scale (NIPS)" and "Observation Form" were utilized. The whole process was video-recorded.

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
5 Days 至 15 Days(Child)
性别
All
接受健康志愿者

入选标准

  • being a healthy term neonates,
  • being 5-15 days,
  • taking of blood sample for Guthrie test routinely.

排除标准

  • admitted to the neonatal intensive care units
  • his/her being taken any analgesics prior to the intervention,
  • having any congenital anomalies

结局指标

主要结局

Neonate Infant Pain Scale Score

时间窗: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)

Neonate Infant Pain Scale score calculated before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus. It is a 6-itemed scale developed to assess the pain occuring due to interventions implemented to term and premature infants. The scoring of the scale was realized by assessing five behavioral classification (mimics, crying, movements of arms and legs, wakefulness state) and one physological parameter (type of respiration). It needs too much time and is difficult to assess intubated infants. It is suitable for painful conditions of non-intubated infants . Total score calculated. The lowest score of the scale is 0; the highest one is 7 and 3+ score shows the presence of pain.

次要结局

  • Duration of Crying(Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes))

研究者

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

cagri covener ozcelik

Associate Professor

Marmara University

研究点 (1)

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