the Effect of White Noise on Sucking and Baby Comfort

Sucking Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04807647
• Other study ID #: 12102020100153
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: November 2021
• Source: Zonguldak Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 68
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 34 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Sucking Behavior

Intervention

Other:
• Orhan OSMAN's track "Don't Let Your Baby Cry" in the "Kolik" album will be played on the music player.
white noise will be played while breastfeeding

Locations

Country	Name	City	State
Turkey	Zonguldak Bülent Ecevit Egitim Arastirma Research Hospital	Zonguldak

Sponsors (1)

Lead Sponsor	Collaborator
Esra Tanriverdi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2-6 month