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

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Newborn; Neonatal Intensive Care Unit; Neonatal Intensive Care; Nursing Care; Neonatal Care; Physiological Parameters
• Intervention / Treatment: Other: Wearing a Sleep Cap

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Efeler
    • Aydin, Efeler, Turkey (Türkiye)
      • Aydın Adnan Menderes University, Faculty of Nursing, Department of Child Health and Disease Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).	For three days, between 19:00 and 07:00

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: sleep; Newborn; Nursing care; Neonatal Intensive Care Unit; Physiological variables; neonatal care
• Other Study ID Numbers: Experimental Study 2019/158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Datasets that are continuously and/or analyzed during the current study can be obtained from the author upon request.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No