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临床试验/NCT04811742
NCT04811742已完成不适用

Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn

Okan University2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2018年9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
69
试验地点
2
主要终点
heart rate

研究概览

简要总结

Effect of immersion bathing and showering applications on comfort level and physiological parameters of Newborn

详细描述

This study aims to determine the effect of immersion bathing and showering on comfort levels and physiological parameters of newborns in neonatal intensive care units.

This is a randomized controlled experimental study. The sample consisted of a total of 69 newborns who were born at the 37th gestational week and above, were referred to the neonatal intensive care unit of a training and research hospital, and met the study inclusion criteria. Study groups were determined through randomization by throwing a dice (immersion bathing group:35, showering group:34). Environmental variables were kept the same for both groups. Physiological parameters (respiration, high heart rate, oxygen saturation, body temperature) and comfort levels of newborns in both groups were compared before, just after and 15 minutes after the bath. Their comfort levels were measured using the Newborn Comfort Behavior Scale (NCBS).

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
37 Weeks 至 40 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Being a newborn born at the 37th gestational week and above,
  • Completing 24 hours following the birth
  • Having a stable condition (no tachycardia and bradycardia)

排除标准

  • Having respiratory failure and distress (having respiratory rate between 30-60, not being monitored in the ventilator, having oxygen saturation of 90% and above, having no need for high concentrations of oxygen via methods such as Hood and CPAP)
  • Having signs of infection, fever and hypothermia (having an ideal body temperature between 36-37.3 ℃)
  • Having neurological problems (hypotonia, hypertonics, etc.), no history of convulsions, using no sedative medication, and having a normal cranial USG.

结局指标

主要结局

heart rate

时间窗: 1 minute

body tempreture

时间窗: 1 minute

Newborn Comfort Behavior Scale (NCBS)

时间窗: 2 minute

The scale was developed by Dijk et al. (2009), and its Turkish validity and reliability study was performed by Kahraman et al. (2014). This is a five-point Likert type scale with six factors: alertness, calmness/agitation, respiratory response, physical movement, crying, muscle tone, and facial tension. The NCBS is used by nurses to assess the baby's comfort, pain and distress. Total score ranges from 6 to 30. A lower score indicates a higher newborn comfort level. A total score between 9-13 indicates that the baby is "comfortable", whereas a total score between 14-30 indicates that the baby has pain and distress, that is, is "uncomfortable" and needs comfort enhancing interventions.

Respiratory rate

时间窗: 1 minute

oxygen saturation

时间窗: 1 minute

次要结局

未报告次要终点

研究者

发起方
Okan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülzade Uysal

Principal Investigator

Okan University

研究点 (2)

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