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临床试验/NCT05520164
NCT05520164已完成不适用

Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection: A Randomized Controlled Study

Saglik Bilimleri Universitesi2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10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
The Newborn Infant Pain Scale (NIPS)

研究概览

简要总结

This study was carried out to determine the effect of maternal heart sound listened to by newborns during heel blood collection on pain level and crying time.

详细描述

The randomized controlled and experimental study was conducted with 60 newborns applied to a public family health center for heel blood collection. The infants in the experimental group (n=30) were listened to the maternal heart sound before, during, and after the heel blood collection procedure, and routine blood collection was applied to the control group (n=30). Newborn Information Form and Newborn Infant Pain Scale (NIPS) were used to collect data.

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
Single (Outcomes Assessor)

盲法说明

The two separate clinicians conducting the assessment were masked to allow for impartiality.

入排标准

年龄范围
2 Days 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age of 38-41 weeks,
  • Chronological age of 2-28 days,
  • Without any physical, metabolic or genetic disease,
  • Newborns who did not use any analgesic drugs before the procedure

排除标准

  • Newborns whose heel blood cannot be taken at once

结局指标

主要结局

The Newborn Infant Pain Scale (NIPS)

时间窗: 15 minutes

The Newborn Infant Pain Scale (NIPS) was used. NIPS: Scale Lawrence et al. (1993) was developed to evaluate the behavioral and physiological pain responses of preterm and term infants. The scale consists of five behavioral factors (facial expression, crying, arousal, arm and leg movements) and one physiological (breathing pattern) factor. The crying factor is given 0-1-2 points, the other factors are given 0-1 points, and the total score is between 0-7. A high score indicates greater severity of pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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