Actively Recruiting
Investigation of the Effect of Music on the Stress of Preterm Neonates Through Innovative Applications
Led by University of West Attica · Updated on 2025-04-01
70
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of West Attica
Lead Sponsor
G
General and Maternity Hospital of Athens Elena Venizelou
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how daily music intervention affects stress levels in live born preterm neonates admitted to a Neonatal Intensive Care Unit. This prospective randomized clinical trial aims to compare stress-related salivary biomarkers between neonates exposed to recorded music and those who are not, to see if music can reduce stress caused by the NICU environment. The study focuses on preterm infants born between 28 and 36+6 weeks of gestation. Neonates enrolled will be randomly assigned to either receive standard care without music or to an intervention group exposed to recorded music played through a portable Bluetooth speaker placed inside the incubator. The music sessions, lasting up to 30 minutes, will be conducted daily for 5 consecutive days, starting 30 minutes after feeding if applicable, with close monitoring to ensure safety and minimal other auditory disturbances. Participants will have salivary samples collected daily before and after music sessions to measure stress hormones, enzymes, and proteins. Additional monitoring includes heart rate, respiratory rate, oxygen saturation, blood pressure, weight, head circumference, milk intake, and hospitalization length. The study will assess these measures over 5 days and monitor hospitalization outcomes for up to 6 months, aiming to understand the effects of music on stress and recovery in preterm neonates.
CONDITIONS
Brief Title
Investigation of the Effect of muSic on the Stress of Preterm neONates Through innovATive Applications (SONATA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Diagnosis of brain injury after enrollment
- Negative auditory brainstem response before discharge
- Clinical deterioration
AI-Screening
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Your Study Journey
Duration - Up to 1 week before enrollment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - 5 consecutive days
Participants receive either standard care or a music intervention. Neonates in the music group listen to recorded music through a speaker placed in the incubator for up to 30 minutes daily, under close monitoring.
Daily visits for intervention and assessments
Duration - 5 consecutive days during treatment
Participants undergo daily collection of salivary samples and routine measurements including heart rate, respiratory rate, oxygen saturation, blood pressure, weight, and head circumference to assess stress biomarkers and health status.
Daily visits aligned with treatment sessions
Trial Site Locations
Total: 2 locations
1
General and Maternity Hospital of Athens Elena Venizelou
Athens, Greece, 11521
Actively Recruiting
2
Attikon General University Hospital
Chaïdári, Greece, 12462
Not Yet Recruiting
Research Team
D
Dimitra Metallinou, Assistant Professor
M
Maria Tzeli, PhD candidate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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