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临床试验/NCT04851353
NCT04851353已完成不适用

Breast Milk as Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures

National Defense Medical Center, Taiwan1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年9月26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
250
试验地点
1
主要终点
Infants' pain reponse

研究概览

简要总结

The study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures.

详细描述

Newborns undergo many necessary invasive procedures for routine care, but these treatments may cause stress and pain. The study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures. This study was a prospective, randomized controlled trial. Infants were recruited by convenience sampling in a baby room of a medical center in northern Taiwan from September in 2017 to September in 2018. Newborns who met the criteria were recruited by blocked random to three treatment groups: (1)Gentle touch + Verbal comfort, (2) Smell + gentle touch + Verbal comfort, (3) Smell + Taste + Touch + Verbal comfort. Pain response was measured by the Neonatal Infant Pain Scale (NIPS). The physical distress events were measured by the abnormal heart rate and oxygen saturation event, and crying event. All data were collected 5 minutes before heel-stick (baseline), during heel-stick and in recovery status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Gestational age > 36 weeks, birth weight > 2200 g, and at least one parent agreed to participate.

排除标准

  • had congenital anomalies and neurologic impairment

结局指标

主要结局

Infants' pain reponse

时间窗: Six months

Neonatal Infant Pain Scale

次要结局

  • The distress events of physiological parameters(Six months)

研究者

发起方
National Defense Medical Center, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsiang-Yun Lan

Assistant professor

National Defense Medical Center, Taiwan

研究点 (1)

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