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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07423962
Enrollment
53
Registered
2026-02-20
Start date
2020-09-01
Completion date
2021-03-31
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Physiological variables, Newborn, sleep, Neonatal Intensive Care Unit, neonatal care, Nursing care

Brief 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.

Interventions

OTHERWearing 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.

Sponsors

Aydin Adnan Menderes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Evaluated by a pediatrician independent of the study

Intervention model description

stratified randomization newborns between 32 and 37 weeks of gestation were matched stratified with newborns between 38 and 42 weeks of gestation

Eligibility

Sex/Gender
ALL
Age
32 Weeks to 42 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Infant's Night Sleep DurationFor 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 InfantsFor three days, between 19:00 and 07:00During 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 RateFor three days, between 19:00 and 07:00The 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 RateFor three days, between 19:00 and 07:00The 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 saturationFor three days, between 19:00 and 07:00Oxygen 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 TemperatureFor three days, between 19:00 and 07:00The 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026