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

May 21, 2026 updated by: Barbara Sgobbi, Ospedale di Circolo - Fondazione Macchi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy
      • Varese, Italy, Italy
        • Barbara Sgobbi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 months (Child)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale di Circolo - Fondazione Macchi

Investigators

  • Principal Investigator: Barbara Sgobbi, Tincontro Onlus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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