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
50 participants
INTERVENTIONAL
2019-05-28
2020-05-20
Brief Summary
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Music therapy has real effects on the pain level already proven in adults units. Our objective is to apply this technic to children. The investigators will evaluate this technic during cleaning care which is daily procedure for each stable patient and wich may be painful in this population.
Detailed Description
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Usually those situation require the use of painkillers. For several years, new approaches are used in order to decrease the pain level without medication such as hypnosis or music therapy. Music therapy proved efficacy to reduce pain in different procedures and is currently used in adult intensive care units in order to decrease anxiety and pain.
One specific program, "Music Care" is based on a "U sequence" which use tempo and rhythm variations following the U scheme, to relax patients.
This program will be evaluated in our department and the investigators will study the effects on the pain level during a cleaning care .
The patients will be evaluated during two consecutive cleaning cares. One with and the other without music therapy. The investigators will compare the variation of the FLACC scores (before and during cleaning care ) to show a difference between both methods. The order (with or without) will be randomized. The patient will be his one control.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Music Therapy during cleaning care 1
This group receives music therapy during cleaning care 1 and not during the cleaning care 2.
Each patient will act as their own control
Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.
Each child will benefit two cleaning cares during hospitalization. One with music therapy and the other without music therapy.
Every time, the preparation will be the same with an equipment installation in order to keep comparability and blind.
Child will be videotaped without sound during the care. The order of music therapy intervention will be randomized.
Music Therapy during cleaning care 2
This group receives music therapy during cleaning care 2 and not during the cleaning care 1.
Each patient will act as their own control
Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.
Each child will benefit two cleaning cares during hospitalization. One with music therapy and the other without music therapy.
Every time, the preparation will be the same with an equipment installation in order to keep comparability and blind.
Child will be videotaped without sound during the care. The order of music therapy intervention will be randomized.
Interventions
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Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.
Each child will benefit two cleaning cares during hospitalization. One with music therapy and the other without music therapy.
Every time, the preparation will be the same with an equipment installation in order to keep comparability and blind.
Child will be videotaped without sound during the care. The order of music therapy intervention will be randomized.
Eligibility Criteria
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Inclusion Criteria
* Vigil child
* Admitted to the department of Pediatric Critical Ill Unit at University Hospital in Montpellier (France)
* Signed both parental consent.
* Signed both parental authorization for videotape recording
* Parents or person with legal authority who speaks and understands french
Exclusion Criteria
* Refusal of the child to participate in the study
6 Months
15 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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Hopital Arnaud de Villeneuve- CHU Montpellier
Montpellier, , France
Countries
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References
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Mounier S, Cambonie G, Baleine J, Le Roux M, Bringuier S, Milesi C. Music Therapy During Basic Daily Care in Critically Ill Children: A Randomized Crossover Clinical Trial. J Pediatr. 2024 Jan;264:113736. doi: 10.1016/j.jpeds.2023.113736. Epub 2023 Sep 16.
Other Identifiers
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UF 7654
Identifier Type: -
Identifier Source: org_study_id