The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial
4 april 2021 uppdaterad av: noa ziv, Rabin Medical Center
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
52
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Petach Tikva, Israel, 4920235
- Schneider Children's Medical Center of Israel
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
Inte äldre än 2 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
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Music composed by Mozart, a musical piece 24 minutes long.
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Aktiv komparator: 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.
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Instrumental music , a musical piece 24 minutes long
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Aktiv komparator: Silence
An Mp3 player, upload with silence.
Silence was played using headphones suitable and approved for use in children.
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Silence, a piece 24 minutes long.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change in disease severity
Tidsram: 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).
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Evaluated by Modified Tal Score (Respiratory rate, O2 saturation, use of accessory respiratory muscles, breath sounds: wheezing)
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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).
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Noa Ziv, MD, Schneider Children's Medical Center, Israel
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2018
Primärt slutförande (Faktisk)
28 februari 2019
Avslutad studie (Faktisk)
31 januari 2021
Studieregistreringsdatum
Först inskickad
29 mars 2021
Först inskickad som uppfyllde QC-kriterierna
4 april 2021
Första postat (Faktisk)
6 april 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 april 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 april 2021
Senast verifierad
1 april 2021
Mer information
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0755-17
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