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

Sponsor
Ospedale di Circolo - Fondazione Macchi (Other)
Overall Status
Completed
CT.gov ID
NCT04049526
Collaborator
(none)
30
1
4.9
6.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The influence of different music genres on Heart Rate Variability (HRV) in preterm infants

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 Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Premature Newborns: An Italian Pilot Study
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Jun 30, 2019
Actual Study Completion Date :
Jun 30, 2019

Outcome Measures

Primary Outcome Measures

  1. 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 Criteria

Criteria

Ages Eligible for Study:
1 Day to 90 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barbara Sgobbi Varese Italy

Sponsors and Collaborators

  • Ospedale di Circolo - Fondazione Macchi

Investigators

  • Principal Investigator: Barbara Sgobbi, Tincontro Onlus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Barbara Sgobbi, Musicotherapist, Ospedale di Circolo - Fondazione Macchi
ClinicalTrials.gov Identifier:
NCT04049526
Other Study ID Numbers:
  • 51
First Posted:
Aug 8, 2019
Last Update Posted:
Aug 9, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Barbara Sgobbi, Musicotherapist, Ospedale di Circolo - Fondazione Macchi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2019