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

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833686
• Other study ID #: 0755-17
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2021
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 31, 2021
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Behavioral:
• Mozart
Music composed by Mozart, a musical piece 24 minutes long.
• Instrumental music
Instrumental music , a musical piece 24 minutes long
• Silence
Silence, a piece 24 minutes long.

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease severity	Evaluated by Modified Tal Score (Respiratory rate, O2 saturation, use of accessory respiratory muscles, breath sounds: wheezing)	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).

External Links

•   WHO work on noise