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

Sponsor
Rabin Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04833686
Collaborator
(none)
52
1
3
36
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mozart
  • Behavioral: Instrumental music
  • Behavioral: Silence
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
Feb 28, 2019
Actual Study Completion Date :
Jan 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sonata for 2 pianos in D major, K.488 by Mozart

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

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

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

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

Behavioral: Instrumental music
Instrumental music , a musical piece 24 minutes long

Active Comparator: Silence

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

Behavioral: Silence
Silence, a piece 24 minutes long.

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 2 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Schneider Children's Medical Center of Israel Petach Tikva Israel 4920235

Sponsors and Collaborators

  • Rabin Medical Center

Investigators

  • Principal Investigator: Noa Ziv, MD, Schneider Children's Medical Center, Israel

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
noa ziv, MD, Schneider Children's Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT04833686
Other Study ID Numbers:
  • 0755-17
First Posted:
Apr 6, 2021
Last Update Posted:
Apr 6, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by noa ziv, MD, Schneider Children's Medical Center, Israel
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2021