The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Mozart
Instrumental music
Silence
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Double blind randomized controlled study, Prospective
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
Sites / Locations
- Schneider Children's Medical Center of Israel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Sonata for 2 pianos in D major, K.488 by Mozart
Instrumental music ("To the Point", by Dean Evenson & Tom Barabas)
Silence
Arm Description
An Mp3 player, upload with music by Mozart. Music was played using headphones suitable and approved for use in children.
An Mp3 player, upload with instrumental music. Music was played using headphones suitable and approved for use in children.
An Mp3 player, upload with silence. Silence was played using headphones suitable and approved for use in children.
Outcomes
Primary Outcome Measures
Change in disease severity
Evaluated by Modified Tal Score (Respiratory rate, O2 saturation, use of accessory respiratory muscles, breath sounds: wheezing)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04833686
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Double blind randomized controlled study, Prospective
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sonata for 2 pianos in D major, K.488 by Mozart
Arm Type
Active Comparator
Arm Description
An Mp3 player, upload with music by Mozart. Music was played using headphones suitable and approved for use in children.
Arm Title
Instrumental music ("To the Point", by Dean Evenson & Tom Barabas)
Arm Type
Active Comparator
Arm Description
An Mp3 player, upload with instrumental music. Music was played using headphones suitable and approved for use in children.
Arm Title
Silence
Arm Type
Active Comparator
Arm Description
An Mp3 player, upload with silence. Silence was played using headphones suitable and approved for use in children.
Intervention Type
Behavioral
Intervention Name(s)
Mozart
Intervention Description
Music composed by Mozart, a musical piece 24 minutes long.
Intervention Type
Behavioral
Intervention Name(s)
Instrumental music
Intervention Description
Instrumental music , a musical piece 24 minutes long
Intervention Type
Behavioral
Intervention Name(s)
Silence
Intervention Description
Silence, a piece 24 minutes long.
Primary Outcome Measure Information:
Title
Change in disease severity
Description
Evaluated by Modified Tal Score (Respiratory rate, O2 saturation, use of accessory respiratory muscles, breath sounds: wheezing)
Time Frame
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).
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noa Ziv, MD
Organizational Affiliation
Schneider Children's Medical Center, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children's Medical Center of Israel
City
Petach Tikva
ZIP/Postal Code
4920235
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://www.euro.who.int/en/health-topics/environment-and-health/noise
Description
WHO work on noise
Learn more about this trial
The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial
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