The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial
NCT ID: NCT04833686
Last Updated: 2021-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2018-02-01
2021-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Mozart
Music composed by Mozart, a musical piece 24 minutes long.
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.
Instrumental music
Instrumental music , a musical piece 24 minutes long
Silence
An Mp3 player, upload with silence. Silence was played using headphones suitable and approved for use in children.
Silence
Silence, a piece 24 minutes long.
Interventions
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Mozart
Music composed by Mozart, a musical piece 24 minutes long.
Instrumental music
Instrumental music , a musical piece 24 minutes long
Silence
Silence, a piece 24 minutes long.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Children who were not able to maintain listening for at least 10 minutes were excluded from data analysis
2 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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noa ziv
MD
Principal Investigators
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Noa Ziv, MD
Role: PRINCIPAL_INVESTIGATOR
Schneider Children's Medical Center, Israel
Locations
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Schneider Children's Medical Center of Israel
Petah Tikva, , Israel
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Warren JD. Variations on the musical brain. J R Soc Med. 1999 Nov;92(11):571-5. doi: 10.1177/014107689909201108. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Jenkins JS. The Mozart effect. J R Soc Med. 2001 Apr;94(4):170-2. doi: 10.1177/014107680109400404. No abstract available.
Goines L, Hagler L. Noise pollution: a modem plague. South Med J. 2007 Mar;100(3):287-94. doi: 10.1097/smj.0b013e3180318be5.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
W. J. Dixon. BMDP Statistical Software. 1993.
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.
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.
Related Links
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WHO work on noise
Other Identifiers
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0755-17
Identifier Type: -
Identifier Source: org_study_id
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