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临床试验/NCT07128173
NCT07128173已完成不适用

The Effect of Incubator Covers on the Sleep-wake Cycles of Newborn Babies: A Randomized Controlled Study

Bozok University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年10月15日最近更新:

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
Sleep efficiency (pre-test)

研究概览

简要总结

This study investigated the effect of incubator covers on sleep-wakefulness in premature infants.The study was conducted using a randomised controlled experimental design. The study population consisted of premature in the 30-37 gestational week range who were admitted to the NICU of a hospital located in the Central Anatolia Region. The sample comprised 64 premature infants, who were divided into an incubator cover group (n = 32) and a control group (n = 32). Data were collected using a neonatal follow-up form and actigraphy. The incubator cover group received a 24-hour covers application. The control group received routine nursing care without any additional interventions. Pre-test and post-test assessments were conducted in both groups, and the 24-hour sleep patterns of the newborns were evaluated using actigraphy.

详细描述

Objective

This study investigated the effect of incubator covers on sleep-wakefulness in premature infants.

Materials and Methods

The study was conducted using a randomised controlled experimental design. The study population consisted of premature in the 30-37 gestational week range who were admitted to the NICU of a hospital located in the Central Anatolia Region. The sample comprised 64 premature infants, who were divided into an incubator cover group (n = 32) and a control group (n = 32). Data were collected using a neonatal follow-up form and actigraphy. The incubator cover group received a 24-hour covers application. The control group received routine nursing care without any additional interventions. Pre-test and post-test assessments were conducted in both groups, and the 24-hour sleep patterns of the newborns were evaluated using actigraphy.

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

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

入选标准

  • Newborn babies in the Neonatal Intensive Care Unit who were born at 30-37 weeks of gestation.
  • A birth weight of 1500 grams or more. Stable vital signs
  • Corrected gestational age of 30-37 weeks (plus 7-10 days). Those between 7 and 10 days old

排除标准

  • Those requiring high-frequency mechanical ventilation.
  • Those receiving sedative treatment.
  • Those with hyperbilirubinemia
  • Infants with hypoglycaemia or hyperglycaemia

结局指标

主要结局

Sleep efficiency (pre-test)

时间窗: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)

sleep parametres

Sleep duration minutes (pre-test)

时间窗: 24-hour sleep durations were recorded again by actigraphy (pre-test)

sleep parametres

Number of awakenings of the infant during sleep (pre-test)

时间窗: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)

sleep parametres

Wakefulness time minutes (pre-test)

时间窗: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)

sleep parametres

Sleep efficiency (post-test)

时间窗: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

sleep parametres

Sleep duration minutes (post-test)

时间窗: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

sleep parametres

Wakefulness time minutes (post-test)

时间窗: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

sleep parametres

Number of awakenings of the infant during sleep (post-test)

时间窗: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

sleep parametres

次要结局

未报告次要终点

研究者

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

Ayşe Belpınar

Lecturer

Bozok University

研究点 (1)

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