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

NCT07423962 | Completed

• 1 other identifier: Experimental Study 2019/158
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

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.

Other: Wearing a Sleep Cap

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.

Interventions

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.

Sleep caps group:Newborns in the experimental group were fitted sleep caps

Eligibility Criteria

• Age: 32 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns who are over 32 weeks gestation and are hospitalized in the NICU
• Newborns stable in room air conditions

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University, Faculty of Nursing, Department of Child Health and Disease Nursing

Aydin, Efeler, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluated by a pediatrician independent of the study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: February 20, 2026
• Study Start: September 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication
• 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.

Locations

TU (1)