跳至主要内容
临床试验/NCT04049526
NCT04049526已完成不适用

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

Ospedale di Circolo - Fondazione Macchi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Heart Rate Variability (HRV) variation in preterm infants according to different music genres listening

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Day 至 90 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Ospedale di Circolo - Fondazione Macchi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Sgobbi

Musicotherapist

Ospedale di Circolo - Fondazione Macchi

研究点 (1)

Loading locations...

相似试验