Music Therapy During NIV Implantation in Pediatric Intensive Care Units

Recruiting now · Not applicable

Conditions studied: Acute Respiratory Failure (ARF), Non Invasive Ventilation (NIV)

In brief

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).

Key facts

Study ID

NCT06848218

Run by

University Hospital, Montpellier

People needed

88

Starts

2025-06-18

Expected to finish

2027-04-01

Last updated by the study team

2025-07-01

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 0 to 17 inclusive
• Children hospitalized in pediatric intensive care unit
• Indication for NIV

You may not qualify if…

• - 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 is running

• CHU de MONTPELLIER — Montpellier, France (enrolling)

Full record on ClinicalTrials.gov

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