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

Not Applicable

Completed

• Conditions: Bronchiolitis
• Interventions: Behavioral: Mozart; Behavioral: Instrumental music; Behavioral: Silence

• Registration Number: NCT04833686
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2019-02-28
• Study Completion: 2021-01-31
• Study First Submitted: 2021-03-29
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-04
• Last Update Submitted: 2021-04-04
• Study First Posted: 2021-04-06
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sonata for 2 pianos in D major, K.488 by Mozart	Mozart	An Mp3 player, upload with music by Mozart. Music was played using headphones suitable and approved for use in children.
Instrumental music ("To the Point", by Dean Evenson & Tom Barabas)	Instrumental music	An Mp3 player, upload with instrumental music. Music was played using headphones suitable and approved for use in children.
Silence	Silence	An Mp3 player, upload with silence. Silence was played using headphones suitable and approved for use in children.

Primary Outcome Measures

Name	Time	Method
Change in disease severity	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)

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikva, Israel