About this trial
The goal of this prospective randomized clinical trial is to investigate the effect of music intervention on the stress of live born preterm neonates requiring admission to a Neonatal Intensive Care Unit, through the measurements of salivary biomarkers (hormones and proteins).
The main question it aims to answer is:
Can the daily music intervention reduce the stress levels created by the Neonatal Intensive Care Unit environment in preterm neonates?
Researchers will compare preterm neonates who will not be exposed to music intervention to investigate potential discrepancies in salivary stress biomarkers.
Participants will be exposed to recorded music for 5 consecutive days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Born between 28 - 36+6 weeks of gestation
Absence of active infection including blood, urine, cerebrospinal fluid
Absence of congenital and genetic disorders and chromosomal abnormalities
Absence of nuclear jaundice
Disqualifiers
Diagnosis of brain injury after the enrollment
Negative auditory brainstem response before discharge
Clinical deterioration
Trial design
Parallel
Treatments tested in this trial
Music intervention
Other interventionRecorded music created by a certified music therapist
Treatment groups
Trial outcomes
Primary outcomes
Salivary stress biomarker 1 - Hormone
Concentration of the hormone (Units: μg/dL).
Salivary stress biomarker 2 - Enzyme
Concentration of the enzyme (Units: U/L).
Salivary stress biomarker 3 - Protein
Concentration of the protein (Units: μg/mL).
Secondary outcomes
Heart rate
Measurement of heart rate (beats per minute).
Respiratory rate
Measurement of respiratory rate (breaths per minute).
Oxygen saturation
Measurement of oxygen saturation (percent).
Blood pressure
Measurement of blood pressure (millimeters of mercury).
Sponsors and contacts
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University of West Attica
Lead sponsor
General and Maternity Hospital of Athens Elena Venizelou
Collaborator
Attikon Hospital
Collaborator