the Effect of White Noise on Sucking and Baby Comfort

NCT04807647 | Unknown

• 1 other identifier: 12102020100153
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Sucking Behavior

Keywords

newborn; music; comfort

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Premature comfort scale

  2-6 month

Study Arms (2)

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

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

Eligibility Criteria

• Age: 34 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Esra Tanrıverdi: lead

Study Sites (1)

Zonguldak Bülent Ecevit Eğitim Araştırma Research Hospital

Zonguldak, 67100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sucking Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 19, 2021
• Study Start: December 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)