NCT07423962

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Aydin Adnan Menderes University · Academic / Other
• Sex: All
• Age: 32 Weeks – 42 Weeks
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Newborn
• Neonatal Intensive Care Unit
• Neonatal Intensive Care
• Sleep
• Physiological Parameters
• Nursing Care
• Neonatal Care

Interventions

Type	Name	Description
OTHER	Wearing a Sleep Cap	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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2026-02-20
• Last updated: 2026-02-24

Locations

1 site across 1 country: Turkey (Türkiye)