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

B

Bozok University

Status

Completed

Conditions

Preterm Infants
Sleep

Treatments

Other: Control Group
Other: Incubator Cover Group

Study type

Interventional

Funder types

Other

Identifiers

NCT07128173
YBozokU

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

30 to 37 weeks old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Incubator Cover Group
Experimental group
Description:
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.
Treatment:
Other: Incubator Cover Group
Control Group
Experimental group
Description:
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.
Treatment:
Other: Control Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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