Investigation of the Effect of muSic on the Stress of Preterm neONates Through innovATive Applications (SONATA)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-37
SponsorUniversity of West Attica

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Music intervention

    Other intervention

    Recorded music created by a certified music therapist

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Standard of careNo intervention 0 interventions
Group B: Music interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Salivary stress biomarker 1 - Hormone

Concentration of the hormone (Units: μg/dL).

Time frame
From enrollment to 5 consecutive days.
2

Salivary stress biomarker 2 - Enzyme

Concentration of the enzyme (Units: U/L).

Time frame
From enrollment to 5 consecutive days.
3

Salivary stress biomarker 3 - Protein

Concentration of the protein (Units: μg/mL).

Time frame
From enrollment to 5 consecutive days.

Secondary outcomes

1

Heart rate

Measurement of heart rate (beats per minute).

Time frame
Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.
2

Respiratory rate

Measurement of respiratory rate (breaths per minute).

Time frame
Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.
3

Oxygen saturation

Measurement of oxygen saturation (percent).

Time frame
Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.
4

Blood pressure

Measurement of blood pressure (millimeters of mercury).

Time frame
Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of West Attica

Lead sponsor

General and Maternity Hospital of Athens Elena Venizelou

Collaborator

Attikon Hospital

Collaborator