The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns

NCT04049526 — Completed, 30 participants, Ospedale di Circolo - Fondazione Macchi

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The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Premature Newborns: An Italian Pilot Study

RegistryNCT04049526
StatusCompleted
Study typeObservational
Enrollment30 (Actual)
SponsorOspedale di Circolo - Fondazione Macchi (Other)
ConditionsInfant Behavior, Infant Conditions, Infant Morbidity
InterventionsThe influence of different music genres on Heart Rate Variability (HRV) in preterm infants (Behavioral)
Datesstart 2019-02-01, primary completion 2019-06-30, completion 2019-06-30, first posted 2019-08-08, last updated 2026-05-26
Locations1 site in Italy

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-Summary

AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants.

Neonates undergo a daily randomized music listening program. An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.

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+Detailed description

AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants.

HRV has been previously used to evaluate autonomic nervous system fluctuations in heart rate related to maturation in healthy neonates and in neonates with pathological conditions. This parameter has been used to show how music could improve well-being and the development of the autonomic nervous system in infants.

In this study, neonates (see also inclusion/exclusion criteria), recruited on the basis of birth order, undergo a daily randomized music listening program (25 minutes, every day, for 3 days) based on different music genres listening (soft pop-rap, pop-rock and classical music). Music programs is followed by 1 day of no music monitoring (25 minutes). An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.

+Arms and interventions

  • The influence of different music genres on Heart Rate Variability (HRV) in preterm infants (Behavioral): Neonates undergo a daily randomized music listening program (25 minutes, every day, for 3 days) based on different music genres listening (soft pop-rap, pop-rock and classical music). Music programs is followed by 1 day of no music monitoring (25 minutes). An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure

+Outcome measures

Primary outcomes

  • Heart Rate Variability (HRV) variation in preterm infants according to different music genres listening [Enrollment performed when sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the treatment]: An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.

+Eligibility

Sex: All, ages: 1 Day to 90 Days

Inclusion Criteria:

* gestational age between the 23th and the 32nd week
* birth weight <1500g
* appropriate for gestational age, sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the test

Exclusion Criteria:

* genetic anomalies, chromosomal aberrations, congenital heart malformations, intraventricular haemorrhage (> grade II on ultrasound), periventricular Leukomalacia
* neonates with failed responses to bilateral hearing screening performed by Automated Auditory Brainstem Response testing

+Locations (1)

FacilityCityCountryStatus
Barbara SgobbiVarese, ItalyItaly

+Investigators