the Effect of White Noise on Sucking and Baby Comfort | NCT04807647

NCT04807647

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

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

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

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
music band	Experimental	The starting person will first talk about white noise and explain how he can direct breastfeeding, and fill the Informed Volunteer Form, Patient Identification Form and Application Registration Form. The mother and baby will be given the appropriate position and breastfeeding will be started. No application will be applied to the mother during the first breastfeeding. During the second breastfeeding, 30 newborn group Orhan OSMAN's "Kolik" album will be played on the music player "Your Baby Don't Cry". After the process is completed, a written response will be received for the data Premature Baby Comfort Scale, LATCH breastfeeding diagnostic measurement tool, Patient Diagnosis Form and Application Registration Form.	Other: Orhan OSMAN's track "Don't Let Your Baby Cry" in the "Kolik" album will be played on the music player.
control	No Intervention	First, the mother will be informed about the study. Then the appropriate position will be given. The informed volunteer form, the Patient Identification Form and the Application Registration Form will be filled. The mother and the baby will be given the appropriate position and breastfeeding will be started. No application will be applied to the mother during the first breastfeeding. No intervention will be applied during the second breastfeeding. After the procedure is completed, a written response will be received with the data Premature Infant Comfort Scale, LATCH breastfeeding diagnostic measurement tool, Patient Diagnosis Form and Application Registration Form.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orhan OSMAN's track "Don't Let Your Baby Cry" in the "Kolik" album will be played on the music player.	Other	white noise will be played while breastfeeding	music band

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LATCH Breastfeeding Diagnostic Measurement Tool	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.	2-6 month

Secondary Outcomes

Measure	Description	Time Frame
Premature comfort scale	It was developed to measure the pain and stress levels of 0-18 years old children hospitalized in the intensive care unit. It is considered as 7 parameters such as Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate. Each group is a 5-point Likert type scored from 1 to 5, from bad to good. Accordingly, the comfort of the baby is interpreted on the total score. According to this score, 35 is the lowest and 7 the highest comfort score. A high score on the scale indicates that the baby's comfort level is low. If the total score received is 17, the cut-off value of the scale is the limit for the baby's comfort level, indicating the need for an intervention to reduce pain.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Zonguldak Bülent Ecevit Eğitim Araştırma Research Hospital		Zonguldak		67100	Turkey (Türkiye)

IPD Sharing Statement Module