Clinical trial NCT04833686: The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial
Official title: The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Double blind randomized controlled study
Prospective
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 52
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in disease severity
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center, Israel
name: Noa Ziv, MD
role: PRINCIPAL_INVESTIGATOR
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