RecruitingNot ApplicableNCT06650189

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

Investigation of the Effect of Music on the Stress of Preterm Neonates Through Innovative Applications


Sponsor

University of West Attica

Enrollment

70 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Summary

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

Min Age: 28 WeeksMax Age: 37 Weeks

Inclusion Criteria10

  • 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
  • Absence of endocrine disorders
  • Absence of maternal use of illicit drugs prenatally
  • Non - sedated neonates
  • Positive bilateral transient evoked otoacoustic emissions
  • Stable clinical condition
  • Absence of brain injury

Exclusion Criteria3

  • Diagnosis of brain injury after the enrollment
  • Negative auditory brainstem response before discharge
  • Clinical deterioration

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Interventions

OTHERMusic intervention

Recorded music created by a certified music therapist


Locations(2)

General and Maternity Hospital of Athens Elena Venizelou

Athens, Greece

Attikon General University Hospital

Chaïdári, Greece

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NCT06650189