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临床试验/NCT04602130
NCT04602130已完成不适用

The Effect of Massage, Wipe Bathing and Tub Bathing on Physiological Measurements of Late Premature Newborns: A Randomised Controlled Trial

Inonu University2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2018年1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
192
试验地点
2
主要终点
Changes in pulse

研究概览

简要总结

Purpose: This randomized experimental study aimed to analyze the effect of massage, wipe bathing and tub bathing of late premature newborns on their physiological measurements.

Design and Methods: . This randomized experimental study was conducted on 192 newborns at the gestational week of 34 or higher in the newborn intensive care unit of a university hospital. The researcher applied massage (n: 48), tub bathing (n: 48), and wipe bathing (n: 48) to the newborns. The control group (n: 48) received no intervention except for the routine clinical practices. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form." The statistical analysis was performed using percentages, means, and ANOVA test.

详细描述

The neonatal period covers the postnatal first 28 days. During this period, newborns try to adapt to the extrauterine life after the intrauterine life and stabilize their respiratory and circulatory functions. Therefore, the acquisition of information on newborns' vital signs is crucial in the evaluation of and caregiving for newborns. The increase in evidence-based studies in nursing has led to changes and developments in the caregiving instructions that have hitherto been used in newborn intensive care units. However, the required and effective nursing practices that are considered indispensable in newborn intensive care units may cause various physiological (increase or decrease in heart and respiration rate, temporary decrease in oxygen saturation, hypothermia) and behavioral reactions (crying, uneasiness) Nurses, therefore, should closely monitor newborns' vital signs and make various interventions to keep these signs within normal values, as a primary practice.

The literature includes many studies conducted by nurses that focus on keeping newborns' physiological measurements within normal values. Massage means the stimulation of the soft tissues in the body. Previous studies have indicated that massage has positive effects such as relaxing the muscles, relieving pain, reducing bilirubin values by enabling blood and lymphatic circulation, increasing sleep duration, and strengthening the relationship between mothers and newborns. However, only a limited number of studies exist on the effects of massage on newborns' physiological measurements reported that the tactile stimulus through massages supported premature infants' parasympathetic functions and positively affected the infants' heart rate by reducing neurochemical and stress stimuli. Furthermore, Dieogo et al. (2008) reported that premature infants' body temperature increased due to the increased blood circulation during massage.

The bathing of newborns plays a highly important role in routine newborn clinical care practices, as well as in the individual, aesthetic, cultural, and hygienic benefits it confers. In neonatal intensive care units (NICU), tub baths, wipe baths, swaddle baths and shower-type bathing are commonly used. In Turkey, however, wipe baths and tub baths are often the most commonly used bathing methods in neonatal intensive care units . Although the literature shows differences among the institutions and countries, in newborn care units, wipe bathing is generally carried out by nurses, and tub bathing is not recommended until the infants' naval cord falls of. Numerous studies have shown that bathing can be performed without harming the newborn. Bryanton et al. (2004) indicated in their study that thermoregulation was ensured for the infants by drying them under a radiant warmer and placing them in an incubator. Mörelus et al. (2006) reported that infants might show physiological reactions, such as increased respiration and heart rate, to any stress. They also found that bathing positively affected infants' physiological measurements by relaxing them and reducing their stress levels. Studies that compare the effects of traditional wipe and tub bathing on newborns' physiological measurements have shown that tub bathing had more positive effects than wipe bathing. However, no studies have analyzed in the related literature that investigate the effects of massage, wipe bathing and tub bathing on physiological measurements, in the studies also have several inconsistencies, such as a small sample size, the failure to use control groups and a lack of blinding and follow-up. This randomized experimental study aimed to analyze the effect of massage, wipe bathing and tub bathing of late premature newborns on their physiological measurements.

Study design, setting, and population This study was conducted as a randomised controlled study between January and December 2018 in the NICU of a university hospital in Turkey. The NICU employs 30 nurses who provide newborns with bathing care performed routinely between 2 and 3 pm each afternoon.

In this study, permission to conduct the research was obtained from the hospital and the Inonu University Health Sciences Scientific Research and Publication Ethics Committee. All parents who agreed to participate in the research were informed of its methods and purpose, and each completed an informed consent form.

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 (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • newborns who born at 34 weeks' gestation and over
  • newborns who receiving routine care and who were stable (temperature >36.5 °C, SpO2> 95%, HR = 120-160 / min)
  • newborns who had an apgar score of 7 or higher at the first minute after birth;
  • newborns who at least 24 hours old

排除标准

  • newborns with any health problems that prevent bathing (eg congenital anomaly, surgical intervention, etc.)

结局指标

主要结局

Changes in pulse

时间窗: 30 minutes

Nurses recorded the changes in pulse(HR) of newborns before, immediately after and 30 minutes after the intervention on the Newborn Follow up Survey.

次要结局

  • Changes in respiration(30 minutes)
  • :Changes in oxygen saturation(30 minutes)
  • Changes in body temperature(30 minutes)

研究者

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

Yeliz SUNA DAĞ

Principal Investigator

Inonu University

研究点 (2)

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