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临床试验/NCT07068737
NCT07068737已完成不适用

The Effect of a Structured Bathing Care Package on Comfort and Skin Hydration in Preterm Infants in the Neonatal Intensive Care Unit

Kiymet Aygün1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Neonatal comfort score

研究概览

简要总结

This completed study evaluated the effects of a bathing care package on the comfort level and skin hydration of preterm infants admitted to the neonatal intensive care unit (NICU). Preterm infants, born before 37 weeks of gestation, often experience skin dryness and discomfort due to their immature skin barrier.

The bathing care package involved a gentle bathing procedure using warm water at a specific temperature, performed in a basin with a wrapping technique. This procedure was carried out under controlled room temperature and humidity conditions to maximize infant comfort. Comfort-enhancing techniques were also applied during and after the bath.

Preterm infants were randomly assigned to either the intervention group receiving the bathing care package or the control group receiving the standard bathing care routinely practiced in the NICU.

Data collected throughout the study demonstrated that the bathing care package helped maintain skin hydration and preserve comfort levels better than the standard care.

The findings contribute to improving neonatal nursing protocols aimed at enhancing the well-being of preterm infants.

All procedures were conducted with informed consent from parents or legal guardians and approved by the institutional ethics committee.

详细描述

Background: The first bath of a baby admitted to the Neonatal Intensive Care Unit (NICU) is usually performed in the neonatal intensive care environment. Preparing the intensive care environment before bathing is very important for the newborn's adaptation. Preterm infants, in particular, are more sensitive to stressors encountered during nursing care that negatively affect their neurodevelopment. Bathing is an application that increases comfort in preterm infants, but it is also an application that causes a stress response, so it is important to make bathing less stressful and more comfortable. Bathing is performed using different methods. Studies have shown that the swaddling bath method, one of these methods, increases comfort and reduces stress in preterm infants compared to other methods and better maintains body temperature.

The epidermal barrier begins to form during intrauterine life and continues to develop after birth. The skin of a preterm infant is immature compared to that of a term infant and is still developing. The hydration and moisture of the stratum corneum layer are indicators of skin barrier function and prevent transepidermal water loss (TEWL). In preterm infants, due to inadequate stratum corneum formation, there is a risk of transepidermal water loss and impaired skin barrier function . High transepidermal water loss values indicate that the skin barrier is weakened and allows more water to evaporate from the body. This can lead to dehydration and increased sensitivity to external irritants and pathogens. Low transepidermal water loss values indicate that the skin barrier is functioning well, effectively retaining moisture and protecting against environmental factors . Bathing is a practice that increases skin moisture and protects the skin barrier.

Aim: This study was conducted because there was no existing study in our country that simultaneously examined the effects of skin moisture and comfort levels in preterm infants due to the absence of a standardised care package application that combines optimal bathing conditions. In this study, a bathing care package was developed to increase the comfort level and skin moisture of preterm infants.

Methods: The study was conducted as a pre-test and post-test controlled semi-experimental design. Data were collected using the "Information Form", "Newborn Comfort Scale", and "Follow-up Form". A skin moisture measuring device, bedside monitor, liquid temperature gauge, and room temperature and humidity measuring devices were used to collect data. The study was initiated after obtaining ethical approval and clinical permission. Parents of preterm infants in the control group and the group receiving the care package who met the inclusion criteria were informed about the study, and their written consent was obtained. The study was conducted in the neonatal intensive care unit of a city and teaching research hospital. The sample size was calculated using the "G. Power-3.1.9.2" programme. The effect size was calculated as 0.926, with a 95% confidence interval and 95% power, requiring a total of 64 preterm newborns, with at least 32 in each group.

First, the data for the control group were collected. The control group underwent bathing according to the clinic's routine practice.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
32 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Parental consent to participate in the study
  • •Gestational age between 32 and 37 weeks
  • •Admission to the Neonatal Intensive Care Unit
  • •Spontaneous breathing
  • •Stable physiological parameters
  • •Birth weight above 1500 g
  • •24 hours have passed since birth (WHO)

排除标准

  • •Birth weight below 1500 g
  • •Dependence on mechanical ventilation
  • •Diagnosed with sepsis
  • •Receiving sedatives and/or muscle relaxants
  • •Chromosomal abnormality
  • •Infant of a mother with hepatitis or HIV
  • •Meconium aspiration
  • •Chest tube, central venous catheter, drain, peritoneal dialysis catheter.

研究组 & 干预措施

Bathing care package group

Experimental

bathing care package group

干预措施: bathing care package (Behavioral)

routine bath group

Active Comparator

routine bath group

干预措施: routine bath (Behavioral)

结局指标

主要结局

Neonatal comfort score

时间窗: Before bath, and at 15 and 30 minutes after bath

The comfort level of preterm infants will be assessed using the Neonatal Comfort Behavior Scale (NCBS) at baseline and at 15 and 30 minutes after bathing to determine whether the bathing care package helps maintain comfort. Each item on the scale is scored from 1 to 5, and the evaluation is based on the total score. The total score on the Neonatal Comfort Behavior Scale (NCBS) can range from a minimum of 6 to a maximum of 30. A total score between 14 and 30 indicates that the infant is experiencing pain or distress, is not comfortable, and requires interventions to promote comfort.

Skin moisture level

时间窗: Before bath, and at 15 and 30 minutes after bath

Skin moisture levels of preterm infants will be measured using a non-invasive skin hydration monitor before the bath, and at 15 and 30 minutes after bathing to evaluate the effect of the bathing care package on skin moisture retention.

次要结局

未报告次要终点

研究者

发起方
Kiymet Aygün
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kiymet Aygün

Principal Investigator BSc, MSc Kıymet Aygün

Tarsus University

研究点 (1)

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