The Effect of Lullaby and Breastmilk Smell on Preterm Newborns

March 5, 2024 updated by: Gizem Kerimoğlu Yıldız, Mustafa Kemal University

The Effect of Lullaby and Breastmilk Smell on Physiological Parameters, Comfort and Maternal Attachment Levels of Preterm Newborns

The goal of this clinical trial is to investigate the effect of live lullaby from mother voice, and breast milk smell on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns who are between 35-37 weeks of gestation at the time of the study and the level of pospartum depression of mothers. The main hypothesis are:

H0: The live lullaby from mother voice and breast milk smell have no effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H1: The live lullaby from mother voice has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H2: The breast milk smell has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H3: There is differences between the live lullaby from mother voice and the breast milk smell interventions in terms of preterm newborns' physiological parameters, comfort and maternal attachment levels.

H4: The postpartum depression level of mothers in experimental groups (lullaby group and breast milk group) is lower than the control group.

Participants will be in three groups according to the interventions. The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group). The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk. The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

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

  • Turkey
      • Van, Turkey
        • Van Training and Research 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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Parents' willingness to participate in the study
  • Turkish literate parents
  • Babies between 35-37 weeks of gestation
  • Apgar score of 7 or higher at birth
  • Stability of the baby (near discharge)
  • Having mother's milk

Exclusion Criteria:

  • Parents' reluctance to participate in the study
  • Babies younger than 35 weeks and older than 37 weeks
  • Babies receiving phototherapy
  • Finding a congenital anomaly in infants
  • Apgar score below 7 at birth
  • Being connected to a mechanical ventilator

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: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lullaby Group
The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).
Other: Lullaby group
The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group).
Experimental: Breast milk Group
The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.
Other: Breast milk group
The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk.
Other: Control Group
The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.
Other: Control group
The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate change
Time Frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Heart Rate change before, during and after the intervention
5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Oxygen Saturation change
Time Frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Oxygen Saturation change before, during and after the intervention
5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Respiration Rate change
Time Frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Respiration Rate change before, during and after the intervention
5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Body Temperature change
Time Frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Body Temperature change before, during and after the intervention
5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days.
Comfort level change
Time Frame: 5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days
Premature Infant Comfort Behavior Scale (ComfortNeo) will be used before, during and after the intervention. Each item of this five-point Likert scale is scored from 1 to 5 from bad to good. The baby's comfort is evaluated according to the total score. Accordingly, 30 indicates the lowest and 6 the highest comfort score. A high score on the scale indicates a low level of comfort.
5 minutes before the intervention, during the intervention (5th and 10th minutes) and 5 minutes after the application, for 3 consecutive days
Maternal Attachment
Time Frame: 28 days after discharge
Maternal Attachment Scale This scale consists of 26 items and is in 4-point Likert type. "Always" is calculated as 4 points, "often" as 3 points, "sometimes" as 2 points, and "never" as 1 point. An overall score is obtained from the sum of all items. The lowest score to be obtained from the scale is 26, and the highest score is 104. A high score indicates high maternal attachment.
28 days after discharge
Postpartum Depression
Time Frame: Before the interventions and 28 days after discharge
Edinburgh Postpartum Depression Scale The scale is in the form of a four-point Likert scale and consists of a total of 10 items. Items 1,2 and 4 are scored as 0,1,2,3 and other items as 3,2,1.0. The lowest possible score is 0 and the highest score is 30.
Before the interventions and 28 days after discharge

Collaborators and Investigators

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

Sponsor

Mustafa Kemal University

Collaborators

Yuzuncu Yıl University
Istanbul University - Cerrahpasa (IUC)
Van Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 15, 2023

Primary Completion (Actual)

March 4, 2024

Study Completion (Actual)

March 5, 2024

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hatay Mustafa Kemal University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The researchers have not planned to share any individual participant data yet.

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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