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

NCT ID: NCT05892809

Last Updated: 2023-06-07

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-01-01

Brief Summary

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The aim of this study is to evaluate the effect of an incubator cover on the vital signs of term and preterm neonates hospitalized in a neonatal intensive care unit. Methods: 91 neonates presenting to a neonatal intensive care unit who met the inclusion criteria were included in the study. Vital signs of neonates were measured with and without incubator cover. Measurements were performed three times (0th, 15th, and 30th minute).

Detailed Description

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Term and preterm are exposed to many stimuli during their stay in the neonatal intensive care unite (NICU). These stimuli; operation and alarm sounds of devices, continuous and high level ambient lighting. These stimuli can cause deviations in the physiological indicators of newborns, and hearing and vision loss. The aim of this study is to evaluate the effect of an incubator cover on the vital signs of term and preterm neonates hospitalized in a neonatal intensive care unit. Methods: This study is a prospective repeated measure pretest-posttest repeated-measures design. 91 term and preterm newborns who were hospitalized in the neonatal intensive care unit and met the inclusion criteria were included in this study.

Neonates were admitted to the study if they satisfied all of the following criteria: (1) term and preterms, (2) admitted to NICU, (3) clinically stable, (4) verbal and written consent from the parent. Term and preterm neonates were randomized into two groups (term group = 44, and preterm group = 47 neonates). Vital signs of both groups were measured with and without incubator cover. Measurements were performed three times (0th, 15th, and 30th minute).

Conditions

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Neonatal Disease Nursing Caries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A Pretest-Posttest Repeated Measures Design
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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With incubator cover group and without incubator cover

The incubator cover was covered while the neonate was lying in the incubator. Vital signs were measured at 0th, 15th, and 30th minutes.

Group Type OTHER

use an incubator cover

Intervention Type OTHER

Vital signs of term and preterm newborns were measured separately and with and without an incubator cover.

Interventions

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use an incubator cover

Vital signs of term and preterm newborns were measured separately and with and without an incubator cover.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Parents giving verbal and written consent,
* Hospitalized in the II. Level NICU
* Those born at 38-42 weeks of gestation
* Those born at 24-38 weeks of gestation
* Newborns with a body weight of 1500-2500 grams

Exclusion Criteria

* Having life-threatening health problems
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maltepe University

OTHER

Sponsor Role lead

Responsible Party

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Behice Ekici

Assistant Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenan Çetin, Nurse

Role: PRINCIPAL_INVESTIGATOR

Neonatal Intensive Care Unit

Locations

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Siverek State Hospital

Sanliurfa, Siverek, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MaltepeUniversity

Identifier Type: -

Identifier Source: org_study_id

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