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临床试验/NCT04837326
NCT04837326已完成不适用

Effect of Using White Noise, Embracing and Facilitated Tucking on Physiological Parameters, Crying Duration and Pain During Heel Lance Blood Sampling in Newborns: Randomized Controlled Trial

T.C. ORDU ÜNİVERSİTESİ0 个研究点目标入组 160 人开始时间: 2016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
发起方
入组人数
160
主要终点
Physiological Parameters 2

研究概览

简要总结

This study was conducted to evaluate the effect of using white noise, embracing and facilitated tucking on physiological parameters, crying duration and pain during heel lance blood sampling in healthy newborns.

This study was a prospective, randomized controlled trial. The study was conducted with healthy newborns who were born between 38 and 42 weeks of gestation. The newborns were divided into 4 groups by the applied pain relief methods during heel lance blood sampling in newborns; embracing(n=40), white noise(n=40), facilitated tucking(n=40) and control group (n=40). The physiological changes were evaluated before and after the procedure. NIPS (Neonatal Infant Pain Scale) was used for pain scoring.

详细描述

This study aimed to investigate the effect of white noise, embracing and facilitated tucking on pain during heel lance blood sampling in newborns.

METHODS This randomized-controlled experimental study was performed to evaluate the effect of white noise, embracing and facilitated tucking on pain during heel lance blood sampling in newborns.

Setting and sample:

The study sample consisted of healthy newborns who were born and monitored in the Neonatology Unit of a university hospital. The sample inclusion criteria were gestational age between 38 and 42 weeks, birth weight of 2500 - 4000 g, Apgar score of 8 and higher at 1st and 5th minute, having breastfed at least half an hour before the procedure, not showing any disease symptom, not having congenital anomaly, getting a good hearing test result and not having received any invasive intervention other than Vitamin K and Hepatitis B vaccine.

Sample size:

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
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age between 38 and 42 weeks,
  • birth weight of 2500 - 4000 g,
  • Apgar score of 8 and higher at 1st and 5th minute,
  • having breastfed at least half an hour before the procedure,
  • not showing any disease symptom,

排除标准

  • having congenital anomaly,
  • getting a good hearing test result
  • having received any invasive intervention other than Vitamin K and Hepatitis B vaccine.

结局指标

主要结局

Physiological Parameters 2

时间窗: 15 minutes

SpO2

Physiological Parameters 3

时间窗: 15 minutes

Respiration rate

Neonatal Pain

时间窗: 15 minutes

Neonatal Infant Pain Scale

Crying Duration

时间窗: 15 minutes

Crying durations of the infants.

Physiological Parameters 1

时间窗: 15 minutes

Pulse rate

次要结局

未报告次要终点

研究者

发起方
T.C. ORDU ÜNİVERSİTESİ
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilekkucu Kalemdar

Associate Prof. Dr

T.C. ORDU ÜNİVERSİTESİ

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