The Effect of Wearing a Sleep Cap on the Sleep and Physiological Variables of Infants Hospitalized in the Neonatal Intensive Care Unit: A Randomized Controlled Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Infant's Night Sleep Duration
研究概览
简要总结
This study is a randomized controlled experimental trial designed to evaluate the effects of a researcher-developed sleep cap on the sleep and physiological variables of infants hospitalized in the Neonatal Intensive Care Unit.
详细描述
Sleep is a fundamental requirement for human physiological and psychological well-being. It is neurobiologically vital for brain development, neuroplasticity, motor and language development, learning, and memory. Newborns spend most of their time sleeping, and sleep is the primary behavioral state in the brain development of the newborn. Studies have shown that when newborn sleep is not preserved, neurobiological development, cognitive growth, and academic achievement are negatively affected in later stages of life.
Neonatal Intensive Care Units (NICUs), unlike the intrauterine environment, are stressful settings with bright lights, noise, and painful stimuli. These adverse stimuli negatively affect sleep, physiological parameters, growth, development, and the length of hospital stay. In NICUs, premature infants whose many systems are not yet fully developed are often treated. Therefore, preterm infants, in particular, need greater protection against the negative effects of the intensive care environment.
The literature contains many studies emphasizing the importance of preserving infants' sleep. However, it has been observed that there is no tool designed to simultaneously reduce the light and noise to which infants in intensive care are exposed, while also establishing a light-dark cycle to promote and preserve circadian rhythm development. In response to this need, researchers have developed a sleep cap. The aim of this study is to examine the effects of using this newly developed sleep cap on the sleep and physiological variables of infants hospitalized in the neonatal intensive care unit.
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 (Outcomes Assessor)
盲法说明
Evaluated by a pediatrician independent of the study
入排标准
- 年龄范围
- 32 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns who are over 32 weeks gestation and are hospitalized in the NICU
- •Newborns stable in room air conditions
排除标准
- •Premature infants birth under 32 weeks
- •Newborns receiving phototherapy treatment
- •Newborns receiving respiratory support
- •Newborns with congenital anomalies
- •Newborns receiving medication that affects sleep (such as caffeine)
- •Newborns with sepsis
- •Newborns with congenital diseases
- •Newborns with diseases affecting the central nervous system
研究组 & 干预措施
Sleep caps group:Newborns in the experimental group were fitted sleep caps
Demographic characteristics, clinical findings, and physiological variables (heart rate, respiratory rate, saturation value, and body temperature) of the infants in the study group were recorded. The newborns in the study group were fitted with sleeping hats for three days between 7:00 PM and 7:00 AM, and the hats were removed when they woke. 12 hours of uninterrupted video recording was conducted during this time. The newborns' sleeping and waking times, as well as the reasons for waking, were recorded. The video recordings were viewed and evaluated by both the researcher and an independent expert (pediatrician) from the study.
干预措施: Wearing a Sleep Cap (Other)
Control group
Demographic characteristics, clinical findings, and physiological variables (heart rate, respiratory rate, saturation value, and body temperature) of the infants in the control group were recorded. Newborns in the control group underwent clinical routines for three days, and uninterrupted video recordings were made between 7:00 PM and 7:00 AM. The newborns' sleeping and waking times, as well as the reasons for waking, were recorded. The video recordings were viewed and evaluated by both the researcher and an independent expert (pediatrician) from the study.
结局指标
主要结局
Infant's Night Sleep Duration
时间窗: For three days, between 19:00 and 07:00.
The duration (in minutes) of continuous sleep between 19:00 and 07:00 was determined by watching video recordings from three days of monitoring. For each monitoring day, the average sleep duration (in minutes) over a 12-hour period (19:00-07:00) was determined.
Number of Nighttime Awakenings of the Infants
时间窗: For three days, between 19:00 and 07:00
During three monitoring days, the number of times the ınfant woke up between 19:00 and 07:00 was determined by watching video recordings. For each monitoring day, the number of awakenings in a 12-hour period (19:00-07:00) was determined.
Heart Rate
时间窗: For three days, between 19:00 and 07:00
The infants' heart rate (beats per minute) was monitored using bedside monitors. For each monitoring day, a 12-hour average heart rate (beats per minute) was recorded (between 19:00 and 07:00).
Respiratory Rate
时间窗: For three days, between 19:00 and 07:00
The respiratory rate (respiratory rate/minute) of the infants was monitored using bedside monitors. For each monitoring day, the average respiratory rate (respiratory rate/minute) was taken over 12 hours (between 19:00 and 07:00).
Oxygen saturation
时间窗: For three days, between 19:00 and 07:00
Oxygen saturation (%) of infants was monitored with bedside monitors. For each monitoring day, the 12-hour (between 19:00 and 07:00) average oxygen saturation was taken (%).
Body Temperature
时间窗: For three days, between 19:00 and 07:00
The infant's body temperature (°C) was measured with a thermometer suitable for infants. For each monitoring day, the 12-hour average body temperature (between 19:00 and 07:00) was taken (°C).
次要结局
未报告次要终点
研究者
Esra Bozkurt
Principal Investigator
Aydin Adnan Menderes University