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CompletedNCT04049526Updated May 26, 2026

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

An observational study in Infant Behavior, Infant Conditions and Infant Morbidity, sponsored by Ospedale di Circolo - Fondazione Macchi. Completed at 1 site in Italy. Open to participants aged 1 Day to 90 Days. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Ospedale di Circolo - Fondazione Macchi · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
1 Day to 90 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infant Behavior
  • Infant Conditions
  • Infant Morbidity

Keywords

  • Music
  • Preterm infants
  • Heart Rate Variability
03

Who can participate

Ages eligible
1 Day to 90 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Enrollment performed when sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the test

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

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
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • BehavioralThe influence of different music genres on Heart Rate Variability (HRV) in preterm infants

    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

05

What researchers measure

Primary outcomes

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

    An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure.

    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

06

Study locations

1 site
  • Barbara Sgobbi
    Varese, Italy, Italy
07

Registry details

Key details

Study ID
NCT04049526
Lead sponsor
Ospedale di Circolo - Fondazione Macchi
Responsible party
Barbara Sgobbi (Musicotherapist, Ospedale di Circolo - Fondazione Macchi) — Principal investigator
First posted
Aug 8, 2019
Start date
Feb 1, 2019
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
May 26, 2026

Study contacts

Barbara Sgobbi
principal investigator · Tincontro Onlus

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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