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

NCT04833686 | Completed

• 1 other identifier: 0755-17
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

Double blind randomized controlled study; Prospective

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (3)

Sonata for 2 pianos in D major, K.488 by Mozart

ACTIVE COMPARATOR

An Mp3 player, upload with music by Mozart. Music was played using headphones suitable and approved for use in children.

Behavioral: Mozart

Instrumental music ("To the Point", by Dean Evenson & Tom Barabas)

ACTIVE COMPARATOR

An Mp3 player, upload with instrumental music. Music was played using headphones suitable and approved for use in children.

Behavioral: Instrumental music

Silence

ACTIVE COMPARATOR

An Mp3 player, upload with silence. Silence was played using headphones suitable and approved for use in children.

Behavioral: Silence

Interventions

Mozart BEHAVIORAL

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

Sonata for 2 pianos in D major, K.488 by Mozart

Instrumental music BEHAVIORAL

Instrumental music , a musical piece 24 minutes long

Instrumental music ("To the Point", by Dean Evenson & Tom Barabas)

Silence BEHAVIORAL

Silence, a piece 24 minutes long.

Silence

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, 4920235, Israel

Location

Related Publications (35)

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Related Links

• WHO work on noise

MeSH Terms

Conditions

Bronchiolitis

Interventions

SIR1 protein, S cerevisiae

Condition Hierarchy (Ancestors)

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

Study Officials

• Noa Ziv, MD

  Schneider Children's Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 6, 2021
• Study Start: February 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: January 31, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)