AzTrials
AzTrials

BronchiolitisNCT04833686

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

A study testing Mozart, Instrumental music and Silence in people with Bronchiolitis, run by Rabin Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 2 years
Conditions the study is for
Bronchiolitis
What is being tested?
Mozart, Instrumental music and Silence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteIsrael
Study dates
1 Feb 2018to 31 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 2 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Schneider Children's Medical Center of Israel

    Petah Tikva, 4920235

Other trials in Israel

About this study

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.

Read the 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.

Conditions
Bronchiolitis
Being tested
Mozart, Instrumental music, Silence
Keywords
Double blind randomized controlled study, Prospective
Medical subject headings
Bronchiolitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MozartBehavioural

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

  • Instrumental musicBehavioural

    Instrumental music , a musical piece 24 minutes long

  • SilenceBehavioural

    Silence, a piece 24 minutes long.

Study groups in NCT04833686
Study groupRoleWhat they receive
Sonata for 2 pianos in D major, K.488 by MozartActive comparatorAn Mp3 player, upload with music by Mozart. Music was played using headphones suitable and approved for use in children.
Receives: Behavioral: Mozart
Instrumental music ("To the Point", by Dean Evenson & Tom Barabas)Active comparatorAn Mp3 player, upload with instrumental music. Music was played using headphones suitable and approved for use in children.
Receives: Behavioral: Instrumental music
SilenceActive comparatorAn Mp3 player, upload with silence. Silence was played using headphones suitable and approved for use in children.
Receives: Behavioral: Silence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in disease severity

    Evaluated by Modified Tal Score (Respiratory rate, O2 saturation, use of accessory respiratory muscles, breath sounds: wheezing)

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2021
  2. Study start1 Feb 2018
  3. Primary completion28 Feb 2019
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04833686
Sponsor's protocol ID
0755-17
Status last verified
Apr 2021
First submitted
29 Mar 2021
Last updated
6 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Friedman JN, Rieder MJ, Walton JM; Canadian Paediatric Society, Acute Care Committee, Drug Therapy and Hazardous Substances Committee. Bronchiolitis: Recommendations for diagnosis, monitoring and management of children one to 24 months of age. Paediatr Child Health. 2014 Nov;19(9):485-98. doi: 10.1093/pch/19.9.485.

    PubMed 25414585

  • Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.

    PubMed 25349312

  • Ricci V, Delgado Nunes V, Murphy MS, Cunningham S; Guideline Development Group and Technical Team. Bronchiolitis in children: summary of NICE guidance. BMJ. 2015 Jun 2;350:h2305. doi: 10.1136/bmj.h2305. No abstract available.

    PubMed 26037525

  • Kassis I, Srugo I, Srur S, Horowitz Y, Almagor T, Wolf D, Kra-Oz Z, Kennes Y, Rishpon S, Miron D. [The burden and outcomes of acute bronchiolitis among young children hospitalized in Israel]. Harefuah. 2009 Nov;148(11):748-51, 795, 794. Hebrew.

    PubMed 20027974

  • Kou M, Hwang V, Ramkellawan N. Bronchiolitis: From Practice Guideline to Clinical Practice. Emerg Med Clin North Am. 2018 May;36(2):275-286. doi: 10.1016/j.emc.2017.12.006. Epub 2018 Feb 10.

    PubMed 29622322

  • Hasegawa K, Tsugawa Y, Brown DF, Mansbach JM, Camargo CA Jr. Trends in bronchiolitis hospitalizations in the United States, 2000-2009. Pediatrics. 2013 Jul;132(1):28-36. doi: 10.1542/peds.2012-3877. Epub 2013 Jun 3.

    PubMed 23733801

  • Vaajoki A, Kankkunen P, Pietila AM, Vehvilainen-Julkunen K. Music as a nursing intervention: effects of music listening on blood pressure, heart rate, and respiratory rate in abdominal surgery patients. Nurs Health Sci. 2011 Dec;13(4):412-8. doi: 10.1111/j.1442-2018.2011.00633.x. Epub 2011 Sep 8.

    PubMed 21902776

  • Golino AJ, Leone R, Gollenberg A, Christopher C, Stanger D, Davis TM, Meadows A, Zhang Z, Friesen MA. Impact of an Active Music Therapy Intervention on Intensive Care Patients. Am J Crit Care. 2019 Jan;28(1):48-55. doi: 10.4037/ajcc2019792.

    PubMed 30600227

  • Pauwels EK, Volterrani D, Mariani G, Kostkiewics M. Mozart, music and medicine. Med Princ Pract. 2014;23(5):403-12. doi: 10.1159/000364873. Epub 2014 Jul 19.

    PubMed 25060169

  • Warren JD. Variations on the musical brain. J R Soc Med. 1999 Nov;92(11):571-5. doi: 10.1177/014107689909201108. No abstract available.

    PubMed 10703494

  • Loomba RS, Arora R, Shah PH, Chandrasekar S, Molnar J. Effects of music on systolic blood pressure, diastolic blood pressure, and heart rate: a meta-analysis. Indian Heart J. 2012 May-Jun;64(3):309-13. doi: 10.1016/S0019-4832(12)60094-7.

    PubMed 22664817

  • Uchiyama M, Jin X, Zhang Q, Hirai T, Amano A, Bashuda H, Niimi M. Auditory stimulation of opera music induced prolongation of murine cardiac allograft survival and maintained generation of regulatory CD4+CD25+ cells. J Cardiothorac Surg. 2012 Mar 23;7:26. doi: 10.1186/1749-8090-7-26.

    PubMed 22445281

  • Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19.

    PubMed 27760797

  • Tolunay T, Bicici V, Tolunay H, Akkurt MO, Arslan AK, Aydogdu A, Bingol I. Rhythm and orthopedics: The effect of music therapy in cast room procedures, a prospective clinical trial. Injury. 2018 Mar;49(3):593-598. doi: 10.1016/j.injury.2018.02.008. Epub 2018 Feb 7.

    PubMed 29454656

  • McConnell T, Porter S. Music therapy for palliative care: A realist review. Palliat Support Care. 2017 Aug;15(4):454-464. doi: 10.1017/S1478951516000663. Epub 2016 Oct 24.

    PubMed 27772537

Questions about this trial

What is this clinical trial studying?

A study testing Mozart, Instrumental music and Silence in people with Bronchiolitis, run by Rabin Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in disease severity (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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04833686, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in