The Effect of Music on Maternal Stress and Milk Amount
The Effect of Music Played to Mothers of Premature Babies Inpatient Neonatal Intensive Care Unit on Their Stress Levels and Milk Amount
1 other identifier
interventional
59
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2023
CompletedFirst Submitted
Initial submission to the registry
February 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2024
CompletedJune 11, 2024
June 1, 2024
5 months
February 13, 2024
June 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
amount of breast milk measured at the same time every day
4 months
Secondary Outcomes (1)
State Anxiety Inventory
4 months
Study Arms (2)
Music group
EXPERIMENTALMothers 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.
Control group
NO INTERVENTIONAfter 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Greater than 32-37 weeks of gestation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sağlık Bilimleri Üniversitesi Gazi Yaşargil Eğitim ve Araştırma Hastanesi
Diyarbakır, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
February 13, 2024
First Posted
March 13, 2024
Study Start
November 15, 2023
Primary Completion
April 15, 2024
Study Completion
April 22, 2024
Last Updated
June 11, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share