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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep caps group:Newborns in the experimental group were fitted sleep caps | Experimental | 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. |
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| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearing a Sleep Cap | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | For three days, between 19:00 and 07:00 |
| Heart Rate | 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). | For three days, between 19:00 and 07:00 |
| Respiratory Rate | 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). | For three days, between 19:00 and 07:00 |
| Oxygen saturation | 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 (%). | For three days, between 19:00 and 07:00 |
| Body Temperature | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aydın Adnan Menderes University, Faculty of Nursing, Department of Child Health and Disease Nursing | Aydin | Efeler | Turkey (Türkiye) |
Datasets that are continuously and/or analyzed during the current study can be obtained from the author upon request.
6 months after publication
It must be relevant to the subject of the study and approval from all co-authors must be obtained within 1 month of receiving the request.
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stratified randomization newborns between 32 and 37 weeks of gestation were matched stratified with newborns between 38 and 42 weeks of gestation
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Evaluated by a pediatrician independent of the study
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| For three days, between 19:00 and 07:00 |