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

Study Overview
=================
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.

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

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Behavioral: Mozart
* Behavioral: Instrumental music
* Behavioral: Silence


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sonata for 2 pianos in D major, K.488 by Mozart<br>An Mp3 player, upload with music by Mozart. Music was played using headphones suitable and approved for use in children. | Behavioral: Mozart<br>* Music composed by Mozart, a musical piece 24 minutes long.<br>|
| Active Comparator: Instrumental music (To the Point, by Dean Evenson & Tom Barabas)<br>An Mp3 player, upload with instrumental music. Music was played using headphones suitable and approved for use in children. | Behavioral: Instrumental music<br>* Instrumental music , a musical piece 24 minutes long<br>|
| Active Comparator: Silence<br>An Mp3 player, upload with silence. Silence was played using headphones suitable and approved for use in children. | Behavioral: Silence<br>* Silence, a piece 24 minutes long.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Double blind randomized controlled study, Prospective