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Completed

NCT Number: NCT07128173

The Effect of Incubator Covers on the Sleep-wake Cycles of Newborn Babies: A Randomized Controlled Study

This study investigated the effect of incubator covers on sleep-wakefulness in premature infants.The study was conducted using a randomised controlled experimental design. The study population consisted of premature in the 30-37 gestational week range who were admitted to the NICU of a hospital located in the Central Anatolia Region. The sample comprised 64 premature infants, who were divided into an incubator cover group (n = 32) and a control group (n = 32). Data were collected using a neonatal follow-up form and actigraphy. The incubator cover group received a 24-hour covers application. The control group received routine nursing care without any additional interventions. Pre-test and post-test assessments were conducted in both groups, and the 24-hour sleep patterns of the newborns were evaluated using actigraphy.

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Key information

Conditions

Preterm Infants Sleep

Age range

30 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yozgat Bozok University

Yozgat, Turkey (Türkiye)

About this study

Objective: This study investigated the effect of incubator covers on sleep-wakefulness in premature infants.

Materials and Methods: The study was conducted using a randomised controlled experimental design. The study population consisted of premature in the 30-37 gestational week range who were admitted to the NICU of a hospital located in the Central Anatolia Region. The sample comprised 64 premature infants, who were divided into an incubator cover group (n = 32) and a control group (n = 32). Data were collected using a neonatal follow-up form and actigraphy. The incubator cover group received a 24-hour covers application. The control group received routine nursing care without any additional interventions. Pre-test and post-test assessments were conducted in both groups, and the 24-hour sleep patterns of the newborns were evaluated using actigraphy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborn babies in the Neonatal Intensive Care Unit who were born at 30-37 weeks of gestation.
  • A birth weight of 1500 grams or more. Stable vital signs
  • Corrected gestational age of 30-37 weeks (plus 7-10 days). Those between 7 and 10 days old

Exclusion criteria

  • Those requiring high-frequency mechanical ventilation.
  • Those receiving sedative treatment.
  • Those with hyperbilirubinemia
  • Infants with hypoglycaemia or hyperglycaemia

Treatment and study plan

Incubator Cover Group

Other

Incubator Cover Group: Neonatal information form was filled and consent was obtained.

Actigraphy and 24-hour sleep duration were recorded before incubator cover application.The incubators were covered with incubator covers for 24 hours.24-hour sleep durations were recorded again by actigraphy.

Control Group

Other

Control Group:Neonatal information form was filled and consent was obtained. Actigraphy and 24-hour sleep duration were recorded. No practice other than routine medical treatment follow-up and nursing care was performed.24-hour sleep durations were recorded again by actigraphy.

Primary outcomes

  1. Sleep efficiency (pre-test)

    Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)

    sleep parametres

  2. Sleep duration minutes (pre-test)

    Time frame: 24-hour sleep durations were recorded again by actigraphy (pre-test)

    sleep parametres

  3. Number of awakenings of the infant during sleep (pre-test)

    Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)

    sleep parametres

  4. Wakefulness time minutes (pre-test)

    Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)

    sleep parametres

  5. Sleep efficiency (post-test)

    Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

    sleep parametres

  6. Sleep duration minutes (post-test)

    Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

    sleep parametres

  7. Number of awakenings of the infant during sleep (post-test)

    Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

    sleep parametres

  8. Wakefulness time minutes (post-test)

    Time frame: Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)

    sleep parametres

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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