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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-15

Study Completion Date

2024-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs

NCT05892809

Neonatal Disease Nursing Caries

COMPLETED NA

Preterm Infants Physiological Parameters and Sleep-Wakefulness Status

NCT05673213

Sleep

COMPLETED NA

Effects of Music-Based Interventions on Sleep Patterns and Physiological Responses in Premature Newborns: A Systematic Review and Meta-Analysis

NCT07127419

Sleep Newborn

NOT_YET_RECRUITING

Swaddling and Facilitated Tucking During Nasal CPAP Application

NCT07077148

Respiratory Disease of A Newborn

RECRUITING NA

Sleep-wakefulness Status in Preterm Infants

NCT06664749

Sleep

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Infants Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Incubator Cover Group

Intervention Type 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

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.

Group Type EXPERIMENTAL

Control Group

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes