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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: LISTENING TO THE RECORDINGS SAYING BY PARENTS
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.
Behavioral: LISTENING TO THE RECORDINGS SAYING BY PARENTS
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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