The Effect of Sleep Caps on Sleep and Physiological Parameters in Infants in the Neonatal Intensive Care Unit

Aydin Adnan Menderes University53 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Interventions

Wearing a Sleep CapOTHER

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 caps for three days between 7:00 PM and 7:00 AM, and the caps 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.

Eligibility

Sex: ALLMin age: 32 WeeksMax age: 42 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Newborns who are over 32 weeks gestation and are hospitalized in the NICU * Newborns stable in room air conditions Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Infant's Night Sleep Duration

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.

Time frame: For three days, between 19:00 and 07:00.

Number of Nighttime Awakenings of the Infants

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.