Clinical trial NCT04807647: the Effect of White Noise on Sucking and Baby Comfort
Official title: The Effect of White Noise on Sucking Success and Baby Comfort in Premature Babies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sucking Behavior
Keywords: newborn
music
comfort
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 68
Sex: ALL
Minimum age (years): 34
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: LATCH Breastfeeding Diagnostic Measurement Tool
timeFrame: 2-6 month
Secondary outcomes:
measure: Premature comfort scale
timeFrame: 2-6 month
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit Eğitim Araştırma Research Hospital
Study officials:
References: