- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06307756
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
Conditions
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
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-
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Diyarbakır, Turkey
- Sağlık Bilimleri Üniversitesi Gazi Yaşargil Eğitim ve Araştırma Hastanesi
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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.
Sponsor
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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