NCT06307756

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

February 13, 2024

Last Update Submit

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

EXPERIMENTAL

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.

Other: Music group

Control group

NO INTERVENTION

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.

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.

Music group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

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

Locations