The Effect Of Lullaby Records Sung By The Parent's During Newborn Care On Newborn's

June 25, 2021 updated by: Duygu Akyuz, Kocaeli University

The Effect Of Lullaby Records Sung By The Parent's During Newborn Care On Newborn's And Physical Parameters In Newborn Intensive Care Unit

Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes. The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes. Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care. The data was evaluated in SPSS 21.0 program with convenient statistical methods.İt is detected that heart rate, respiration rateand comfort behiavour scores of the newborns who listen to lullaby in the mother's voice are low compared to the newborns listening to lullaby in the father's voice and those in the control group .

Study Overview

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Izmit
      • Kocaeli, Izmit, Turkey, 41000
        • University of Kocaeli Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Premature babies at 30-37 weeks of gestation,
  • There is no congenital anomaly affecting respiration and spontaneous respiration,
  • No intubation,
  • Absence of congenital or acquired malfarmation related to hearing,
  • Absence of hyperbilirubinemia requiring exchange transfusion,
  • Absence of intrauterine infection (rubella, syphilis, toxoplasma),
  • Absence of intracranial bleeding,
  • No sedative, opioid and anticonvulsant drugs were given before/during the study,
  • Parents' consent to participate in the study,

Exclusion Criteria:

  • Having a diagnosis of asphyxia,
  • Congenital hearing problems in family members,
  • Intubating the baby after starting the research,
  • Parents have a speech impediment,
  • Parents have psychological problems,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mother's voices
Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes. The baby was made listen to the lullaby recorded in the voice of mother's starting with, during and after the care for 10 minutes. Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care.
The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes.
Experimental: father's voices group
Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes. The baby was made listen to the lullaby recorded in the voice of father's starting with, during and after the care for 10 minutes. Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care.
The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes.
No Intervention: control group
Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes.Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of lullaby records sung by the parent's during newborn care on newborns comfort in newborn intensive care unit.
Time Frame: 35 minute
Newborn comfort behavior scale was used for determinain Comfort behiavour scores in this research. Scale got 0 to 35 points (0 (Good) to 35 (Bad).
35 minute
The effect of lullaby records sung by the parent's during newborn care on newborns on the heart beat in newborn intensive care unit.
Time Frame: 35 minute
heart beat- bpm
35 minute
The effect of lullaby records sung by the parent's during newborn care on newborns on the respiration rate in newborn intensive care unit.
Time Frame: 35 minute
respiration rate
35 minute
The effect of lullaby records sung by the parent's during newborn care on newborns on the SpO2 in newborn intensive care unit.
Time Frame: 35 minute
ects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing SpO2
35 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Duygu Akyüz, binayduygu@gmail.com
  • Principal Investigator: Gülzade Uysal, gülzadeuysal@gmail.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

April 5, 2018

Study Completion (Actual)

January 20, 2019

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • KÜ GOKAEK 2018/90

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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