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Completed

NCT Number: NCT04833686

The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial

Bronchiolitis is an infectious disease, with no effective treatment. Music and Mozart's works specifically, has been shown to have a positive effect on physiological parameters, while environmental noise is considered to be harmful. We aimed to evaluate the short-time effect of listening to music and detachment from environmental noise on the severity of bronchiolitis in hospitalized children.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schneider Children's Medical Center of Israel

Petah Tikva, 4920235, Israel

About this study

MP3 player devices were uploaded with 3 different pieces: 1) sonata for 2 pianos in D major, K.488 by Mozart (2) instrumental music ("To the Point", by Dean Evenson & Tom Barabas) and (3) silence. All music or silence pieces were identical in length (24 minutes in accordance to the duration of the sonata).

Music fragments were played using headphones suitable and approved for use in children - GSI (Grason-Standler) Insert Earphone TIP-50 (50 ohm) (Grason Standler Inc. Madison, WI, USA). Sound frequency and volume were adjusted to the age appropriate values33 Children were randomly divided into 3 groups according to the type of intervention. Randomization, numbering of the MP3 players and coding of the content were done by a research coordinator not involved in evaluation of the patients nor in analysis of the results.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 0-24 months, with the clinical diagnosis of bronchiolitis.

Exclusion criteria

  • Children who failed neonatal hearing screening or in whom the results of the screening were not available were excluded from the study.
  • Children who were not able to maintain listening for at least 10 minutes were excluded from data analysis

Treatment and study plan

Mozart

Behavioral

Music composed by Mozart, a musical piece 24 minutes long.

Instrumental music

Behavioral

Instrumental music , a musical piece 24 minutes long

Silence

Behavioral

Silence, a piece 24 minutes long.

Primary outcomes

  1. Change in disease severity

    Time frame: Evaluation was done before music playing and immediately after the end of the music session (At 0 minutes time, and at a maximum time of 24 minutes from the beginning of intervention - which is the length of the musical piece).

    Evaluated by Modified Tal Score (Respiratory rate, O2 saturation, use of accessory respiratory muscles, breath sounds: wheezing)

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Apr 6, 2021
Registry last updated
Apr 6, 2021

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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