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Clinical Trials/NCT04807647
NCT04807647
Unknown
Not Applicable

The Effect of White Noise on Sucking Success and Baby Comfort in Premature Babies

Esra Tanrıverdi1 site in 1 country68 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sucking Behavior
Sponsor
Esra Tanrıverdi
Enrollment
68
Locations
1
Primary Endpoint
LATCH Breastfeeding Diagnostic Measurement Tool
Last Updated
4 years ago

Overview

Brief Summary

The study is a randomized controlled study to determine the effect of white noise on sucking success and infant comfort in newborns in babies aged 34-37 weeks who were fed orally by a full enteral mother in the Neonatal Intensive Care Unit.

Detailed Description

The Type and Purpose of the Research The study is a randomized controlled study to determine the effect of white noise on sucking success and infant comfort in newborn babies between 34-37 weeks of gestation who were fed orally by a full enteral mother hospitalized in the Neonatal Intensive Care Unit. Place and Time of the Study The research was conducted in the Bulent Ecevit Training and Research Hospital Neonatal Intensive Care Unit between 01.09.2020 and 01.03.2021. MATERIAL AND METHOD OF THE RESEARCH The study is a randomized controlled study to determine the effect of white noise on sucking success and infant comfort in newborn babies between 34-37 weeks of gestation who were fed orally by a full enteral mother hospitalized in the Neonatal Intensive Care Unit. Research Universe The universe of the study consisted of newborn babies who were born in the Bulent Ecevit Training and Research Hospital Neonatal Intensive Care Unit between 01.09.2020 and 01.03.2021 and who met the inclusion criteria in the study and the babies who were fed by the mother who passed to the mother's room. Research Sample Thirty control newborn infants who volunteered to participate in the study and met the inclusion criteria were formed by 30 newborns in the white noise group. Sampling Selection Criteria * Gestational age between 34-37 weeks, * Having a birth weight of 1800-3600 g, * Does not have any anatomical and physiological problems, * Does not show any signs of disease and does not have any congenital disorder, * Does not have a congenital or acquired malformation related to hearing * Families without any disability to breastfeed * Having parental consent Materials and Methods In this study, babies who were called to feed mothers who started to be fed orally with breast milk after leaving intensive care were selected. Informed consent form, Patient Identification Form and Application Registration Form, Premature Infant Comfort Scale, and LATCH Breastfeeding Diagnostic Measurement Tool were used for parents who accepted to participate in the study. The control group and the intervention group were first told about white noise and how it could affect breastfeeding, and the Informed Volunteer form, the Patient Identification Form and the Application Registration Form were filled. The mother and the baby were given the appropriate position and breastfeeding was initiated. No application was applied to the mother during the first breastfeeding. During the second breastfeeding, 30 neonatal groups were listened to the song "Your Baby Don't Cry" from Orhan OSMAN's album "Kolik". During the second breastfeeding, no music was played to the control group. After the procedure was completed, the data were collected by the researcher using the Premature Baby Comfort Scale, LATCH breastfeeding diagnostic measurement tool, Patient Diagnosis Form and Application Registration Form. Then the data will be analyzed in the spss 16.0 package program. Data Collection Tools * Introductory Information Form for Mother and Baby * LATCH Breastfeeding Diagnostic Scale * Premature Baby Comfort Scale Decibel measuring device * Orhan Osman's Colic album-Don't Let Your Baby Cry II

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
February 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Esra Tanrıverdi
Responsible Party
Sponsor Investigator
Principal Investigator

Esra Tanrıverdi

Research Assistant

Zonguldak Bulent Ecevit University

Eligibility Criteria

Inclusion Criteria

  • Gestational age between 34-37 weeks,
  • Having a birth weight of 1800-3600 g,
  • Does not have any anatomical and physiological problems,
  • Does not show any signs of disease and does not have any congenital disorder,
  • Does not have a congenital or acquired malformation related to hearing
  • Families without any disability to breastfeed
  • Having parental consent

Exclusion Criteria

  • • Gestational age cannot be between 34-37 weeks
  • Birth weight not in the range of 1800-3600,
  • Having any anatomical and physiological problems
  • Any signs of illness and congenital disorder
  • Having a congenital or acquired malformation related to hearing
  • Families who have any disability to breastfeed
  • No parental consent

Outcomes

Primary Outcomes

LATCH Breastfeeding Diagnostic Measurement Tool

Time Frame: 2-6 month

This measurement tool consists of five evaluation items, a combination of the first letters of these items. The item is between 0 and 2 points. The highest score that can be obtained from the scale is ten. The measurement tool does not have a cut-off point and the higher the LATCH score, the better the breastfeeding success is evaluated.If we look at the five criteria, breast retention, Seeing the swallowing movement of the baby, Type of nipple, Comfort of dyeing the mother's breast and nipple, Holding the baby is the position.

Secondary Outcomes

  • Premature comfort scale(2-6 month)

Study Sites (1)

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