The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial
2021년 4월 4일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
52
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Petach Tikva, 이스라엘, 4920235
- Schneider Children's Medical Center of Israel
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
2년 이하 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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활성 비교기: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in disease severity
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Noa Ziv, MD, Schneider Children's Medical Center, Israel
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 2월 1일
기본 완료 (실제)
2019년 2월 28일
연구 완료 (실제)
2021년 1월 31일
연구 등록 날짜
최초 제출
2021년 3월 29일
QC 기준을 충족하는 최초 제출
2021년 4월 4일
처음 게시됨 (실제)
2021년 4월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 4월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 4월 4일
마지막으로 확인됨
2021년 4월 1일
추가 정보
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