The Effect of Music on Maternal Stress and Milk Amount

June 10, 2024 updated by: Maksude YILDIRIM, Adiyaman University

The Effect of Music Played to Mothers of Premature Babies Inpatient Neonatal Intensive Care Unit on Their Stress Levels and Milk Amount

Premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units. Mothers who plan to return home with their babies during the postpartum period may experience stress due to their children being monitored in intensive care. It is stated that mothers of babies in the neonatal intensive care unit experience stress and anxiety due to reasons such as being separated from their babies, the baby's illness, the baby's sensitive body structure, the baby's appearance and behavior, and the baby's dependence on devices. This stress experienced by mothers of premature babies can prevent mothers from providing enough milk to feed their babies. Mothers whose babies are in the neonatal intensive care unit cannot have adequate contact with their babies and cannot breastfeed; It causes insomnia, stress and anxiety, and the hormonal axis is disrupted, negatively affecting the amount of breast milk. In order to support the healing process of preterm babies, it is important to increase the amount of milk produced by mothers and increase the rate at which babies can receive breast milk. Music improves endothelial function by dilating the vessels; It has been reported that it reduces mental stress by increasing the release of nitrite oxide and endorphins and causes many physiological reactions such as a decrease in blood pressure and pulse. This study will examine the effect of music played to mothers with premature babies on maternal anxiety and the amount of breast milk.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

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

      • Diyarbakır, Turkey
        • Sağlık Bilimleri Üniversitesi Gazi Yaşargil Eğitim ve Araştırma Hastanesi

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Mothers whose babies are born prematurely (gestational age between 32-37 weeks), -whose babies do not have any congenital anomalies,
  • whose babies are not connected to mechanical ventilation,
  • who are over 18 years of age, who are not diagnosed with any psychological disease and
  • who agree to participate in the study will be included in the study.

Exclusion Criteria:

  • Greater than 32-37 weeks of gestation

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music group
Mothers will be informed about the application before the procedure. Mothers who agree to participate in the study will be asked to listen to music that relaxes them for 20 minutes a day for 4 days. The mothers' state anxiety levels and milk quantities will be evaluated before starting the application and every day during the application. Mothers' anxiety levels will be evaluated with the "State Anxiety Inventory". Mothers' anxiety levels and milk quantities will be evaluated every day at 11.45 when they come to the NICU to express milk.
Mothers will be informed about the application before the procedure. Mothers who agree to participate in the study will be asked to listen to music that relaxes them for 20 minutes a day for 4 days. The mothers' state anxiety levels and milk quantities will be evaluated before starting the application and every day during the application. Mothers' anxiety levels will be evaluated with the "State Anxiety Inventory". Mothers' anxiety levels and milk quantities will be evaluated every day at 11.45 when they come to the NICU to express milk.
No Intervention: Control group
After mothers are informed about the study, mothers who agree to participate in the study will be included in the control group by randomization method. No intervention will be made to mothers in the control group. The mothers' state anxiety levels and milk quantities will be evaluated at the first meeting with the mothers and every day for four days. Mothers' anxiety levels will be evaluated with the "State Anxiety Inventory". Mothers' anxiety levels and milk quantities will be evaluated every day at 11.45 when they come to the NICU to express milk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amount of breast milk measured at the same time every day
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
State Anxiety Inventory
Time Frame: 4 months
4 months

Collaborators and Investigators

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

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)

November 15, 2023

Primary Completion (Actual)

April 15, 2024

Study Completion (Actual)

April 22, 2024

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

March 9, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • SayıNo:521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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