search
Back to results

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
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Double blind randomized controlled study, Prospective

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
March 29, 2021
Last Updated
April 4, 2021
Sponsor
Rabin Medical Center
search

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
Citations:
PubMed Identifier
25414585
Citation
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.
Results Reference
background
PubMed Identifier
25349312
Citation
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. Erratum In: Pediatrics. 2015 Oct;136(4):782.
Results Reference
background
PubMed Identifier
26037525
Citation
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.
Results Reference
background
PubMed Identifier
20027974
Citation
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.
Results Reference
background
PubMed Identifier
29622322
Citation
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.
Results Reference
background
PubMed Identifier
23733801
Citation
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.
Results Reference
background
PubMed Identifier
21902776
Citation
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.
Results Reference
background
PubMed Identifier
30600227
Citation
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.
Results Reference
background
PubMed Identifier
25060169
Citation
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.
Results Reference
background
PubMed Identifier
10703494
Citation
Warren JD. Variations on the musical brain. J R Soc Med. 1999 Nov;92(11):571-5. doi: 10.1177/014107689909201108. No abstract available.
Results Reference
background
PubMed Identifier
22664817
Citation
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.
Results Reference
background
PubMed Identifier
22445281
Citation
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.
Results Reference
background
PubMed Identifier
27760797
Citation
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. Erratum In: J Music Ther. 2021 Aug 24;58(3):372.
Results Reference
background
PubMed Identifier
29454656
Citation
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.
Results Reference
background
PubMed Identifier
27772537
Citation
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.
Results Reference
background
PubMed Identifier
30769834
Citation
Stegemann T, Geretsegger M, Phan Quoc E, Riedl H, Smetana M. Music Therapy and Other Music-Based Interventions in Pediatric Health Care: An Overview. Medicines (Basel). 2019 Feb 14;6(1):25. doi: 10.3390/medicines6010025.
Results Reference
background
PubMed Identifier
8413624
Citation
Rauscher FH, Shaw GL, Ky KN. Music and spatial task performance. Nature. 1993 Oct 14;365(6447):611. doi: 10.1038/365611a0. No abstract available.
Results Reference
background
PubMed Identifier
19969615
Citation
Lubetzky R, Mimouni FB, Dollberg S, Reifen R, Ashbel G, Mandel D. Effect of music by Mozart on energy expenditure in growing preterm infants. Pediatrics. 2010 Jan;125(1):e24-8. doi: 10.1542/peds.2009-0990. Epub 2009 Dec 7.
Results Reference
background
PubMed Identifier
26093514
Citation
Coppola G, Toro A, Operto FF, Ferrarioli G, Pisano S, Viggiano A, Verrotti A. Mozart's music in children with drug-refractory epileptic encephalopathies. Epilepsy Behav. 2015 Sep;50:18-22. doi: 10.1016/j.yebeh.2015.05.038. Epub 2015 Jun 18.
Results Reference
background
PubMed Identifier
11317617
Citation
Jenkins JS. The Mozart effect. J R Soc Med. 2001 Apr;94(4):170-2. doi: 10.1177/014107680109400404. No abstract available.
Results Reference
background
PubMed Identifier
17396733
Citation
Goines L, Hagler L. Noise pollution: a modem plague. South Med J. 2007 Mar;100(3):287-94. doi: 10.1097/smj.0b013e3180318be5.
Results Reference
background
Citation
Hsu, T., Ryherd, E. E., Waye, K. P., & Ackerman, J. (2012). Noise pollution in hospitals: Impact on patients. Journal of Clinical Outcomes Management, 19(7), 301-309.
Results Reference
background
PubMed Identifier
29313308
Citation
Gupta A, Gupta A, Jain K, Gupta S. Noise Pollution and Impact on Children Health. Indian J Pediatr. 2018 Apr;85(4):300-306. doi: 10.1007/s12098-017-2579-7. Epub 2018 Jan 9.
Results Reference
background
PubMed Identifier
30449734
Citation
Xyrichis A, Wynne J, Mackrill J, Rafferty AM, Carlyle A. Noise pollution in hospitals. BMJ. 2018 Nov 18;363:k4808. doi: 10.1136/bmj.k4808. No abstract available.
Results Reference
background
PubMed Identifier
26231366
Citation
Stansfeld S, Clark C. Health Effects of Noise Exposure in Children. Curr Environ Health Rep. 2015 Jun;2(2):171-8. doi: 10.1007/s40572-015-0044-1.
Results Reference
background
PubMed Identifier
27546758
Citation
Kramer B, Joshi P, Heard C. Noise pollution levels in the pediatric intensive care unit. J Crit Care. 2016 Dec;36:111-115. doi: 10.1016/j.jcrc.2016.06.029. Epub 2016 Jul 9.
Results Reference
background
PubMed Identifier
27211892
Citation
Ryan KM, Gagnon M, Hanna T, Mello B, Fofana M, Ciottone G, Molloy M. Noise Pollution: Do We Need a Solution? An Analysis of Noise in a Cardiac Care Unit. Prehosp Disaster Med. 2016 Aug;31(4):432-5. doi: 10.1017/S1049023X16000388. Epub 2016 May 23.
Results Reference
background
PubMed Identifier
16187125
Citation
Linares C, Diaz J, Tobias A, De Miguel JM, Otero A. Impact of urban air pollutants and noise levels over daily hospital admissions in children in Madrid: a time series analysis. Int Arch Occup Environ Health. 2006 Feb;79(2):143-52. doi: 10.1007/s00420-005-0032-0. Epub 2005 Sep 27.
Results Reference
background
PubMed Identifier
30321849
Citation
Eze IC, Foraster M, Schaffner E, Vienneau D, Heritier H, Pieren R, Thiesse L, Rudzik F, Rothe T, Pons M, Bettschart R, Schindler C, Cajochen C, Wunderli JM, Brink M, Roosli M, Probst-Hensch N. Transportation noise exposure, noise annoyance and respiratory health in adults: A repeated-measures study. Environ Int. 2018 Dec;121(Pt 1):741-750. doi: 10.1016/j.envint.2018.10.006. Epub 2018 Oct 12.
Results Reference
background
PubMed Identifier
19451078
Citation
Brown G. NICU noise and the preterm infant. Neonatal Netw. 2009 May-Jun;28(3):165-73. doi: 10.1891/0730-0832.28.3.165.
Results Reference
background
PubMed Identifier
20547580
Citation
Wachman EM, Lahav A. The effects of noise on preterm infants in the NICU. Arch Dis Child Fetal Neonatal Ed. 2011 Jul;96(4):F305-9. doi: 10.1136/adc.2009.182014. Epub 2010 Jun 14.
Results Reference
background
PubMed Identifier
22949369
Citation
McCallum GB, Morris PS, Wilson CC, Versteegh LA, Ward LM, Chatfield MD, Chang AB. Severity scoring systems: are they internally valid, reliable and predictive of oxygen use in children with acute bronchiolitis? Pediatr Pulmonol. 2013 Aug;48(8):797-803. doi: 10.1002/ppul.22627. Epub 2012 Sep 4.
Results Reference
background
Citation
W. J. Dixon. BMDP Statistical Software. 1993.
Results Reference
background
PubMed Identifier
29779734
Citation
Finn S, Fancourt D. The biological impact of listening to music in clinical and nonclinical settings: A systematic review. Prog Brain Res. 2018;237:173-200. doi: 10.1016/bs.pbr.2018.03.007. Epub 2018 May 1.
Results Reference
background
PubMed Identifier
29292769
Citation
Guski R, Schreckenberg D, Schuemer R. WHO Environmental Noise Guidelines for the European Region: A Systematic Review on Environmental Noise and Annoyance. Int J Environ Res Public Health. 2017 Dec 8;14(12):1539. doi: 10.3390/ijerph14121539.
Results Reference
background
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

We'll reach out to this number within 24 hrs