Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07128173
Enrollment
64
Registered
2025-08-17
Start date
2023-10-15
Completion date
2024-03-30
Last updated
2025-08-17

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

Conditions

Preterm Infants, Sleep

Keywords

Newborn, incubator cover, sleep,, wakefulness

Brief summary

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.

Detailed description

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.

Interventions

OTHERIncubator Cover Group

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.

OTHERControl Group

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.

Sponsors

Bozok University
Lead SponsorOTHER

Study design

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

Intervention model description

This study was conducted as a randomised controlled experimental study with single-blind methodology.

Eligibility

Sex/Gender
ALL
Age
30 Weeks to 37 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep efficiency (pre-test)Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)sleep parametres
Sleep duration minutes (pre-test)24-hour sleep durations were recorded again by actigraphy (pre-test)sleep parametres
Number of awakenings of the infant during sleep (pre-test)Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)sleep parametres
Wakefulness time minutes (pre-test)Actigraphy and 24-hour sleep duration were recorded before incubator cover application (pre-test)sleep parametres
Sleep efficiency (post-test)Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)sleep parametres
Sleep duration minutes (post-test)Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)sleep parametres
Number of awakenings of the infant during sleep (post-test)Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)sleep parametres
Wakefulness time minutes (post-test)Actigraphy and 24-hour sleep duration were recorded before incubator cover application (post-test)sleep parametres

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026