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

NCT07128173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-08-17

No results posted yet for this study

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.

Conditions

  • Preterm Infants
  • Sleep

Interventions

OTHER

Incubator 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.

OTHER

Control 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 & Collaborators

  • Bozok University

    lead OTHER

Principal Investigators

  • Ayşe Belpınar, pHD · Bozok University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2024-03-15
Completion
2024-03-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128173 on ClinicalTrials.gov