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Music Therapy During NIV Implantation in Pediatric Intensive Care Units

RecruitingNAAges any - 17 YearsAllUniversity Hospital, Montpellier
NCT06848218 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Non-invasive ventilation makes it possible to avoid intubation and improve patients' quality of life. However, pain is associated with discomfort and could lead to failure of this technique. The aim of this study is to measure the effectiveness of music therapy on pain levels during non-invasive ventilation in critically ill children. To this end, a pain score (Face Legs Activity Cry Consolability FLACC) will be assessed by raters blinded to the randomization arm during NIV initiation. The FLACC score will be compared before and during implementation of NIV between two groups: a control group (without music therapy) and an experimental group (with music therapy).

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📋 Eligibility rules (as published)
Target population : Children aged 0 to 17, hospitalized in the pediatric intensive care unit for respiratory failure with indication for NIV. Inclusion Criteria: * Children aged 0 to 17 inclusive * Children hospitalized in pediatric intensive care unit * Indication for NIV Exclusion Criteria: * \- Severe deafness * Clinical condition requiring immediate initiation of NIV * Refusal to allow the child to be photographed * Child not assessable by FLACC score (paralysis of lower limbs, etc.) * Child already receiving NIV respiratory support at home * Participation in other ongoing research involving the human person at major risk and constraint (RIPH category 1) or a drug trial according to European regulation 536/2014. * Absence of affiliation to a French social security scheme or beneficiary of such a scheme. * Subject deprived of liberty (art.L. 1121-6 du CSP) * Failure to obtain free and informed written or oral consent and authorization to take photographs from both parents (or from a single parent if the patient is accompanied by only one parent, in accordance with article 1122-2 of the French Public Health Code) or from the legal guardian and/or child.
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What it tests

  • Music Therapy
  • Setting Up NIV
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Where

1 site
CHU de MONTPELLIER
Montpellier, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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