Music therapy to ease pain during noninvasive ventilation in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children admitted to a pediatric intensive care unit with acute respiratory failure who need noninvasive ventilation will be randomized to receive either standard care or standard care plus a structured "Music Care" program during NIV initiation. Pain will be measured using the FLACC score immediately before and during NIV by raters blinded to group assignment. The Music Care program uses a tempo-and-rhythm "U sequence" designed to induce relaxation. The study compares change in FLACC scores between the music and control groups to see if music reduces procedural pain and improves tolerance of NIV.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU de MONTPELLIER
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Sophie MOUNIER, MD
• Email: s-mounier@chu-montpellier.fr
• Phone: 04 67 33 66 09

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.