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OpenTrials
Completed

NCT Number: NCT04049526

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

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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Key information

Age range

1 day–90 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Barbara Sgobbi

Varese, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Heart Rate Variability (HRV) variation in preterm infants according to different music genres listening

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ospedale di Circolo - Fondazione Macchi

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2019
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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