Music Therapy During NIV Implantation in Pediatric Intensive Care Units

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how music therapy can help reduce pain in critically ill children who need a treatment called non-invasive ventilation (NIV) due to acute respiratory failure. NIV is a method that helps patients breathe without needing a tube placed in their throat, which can be uncomfortable and painful. The researchers want to see if listening to music during the start of NIV makes the experience less painful for the children. They will measure pain levels using a simple scoring system that looks at the child's face, legs, activity level, crying, and how easily they can be comforted.

To participate in this trial, children aged 0 to 17 who are in a pediatric intensive care unit and need NIV might be eligible. However, children with severe deafness, those who need immediate NIV, or those already on NIV at home won't be able to join. If a child does participate, they will be placed in one of two groups: one group will listen to music during their treatment, while the other group will not. The trial is not yet recruiting participants, so those interested should keep an eye out for updates.

Gender

ALL

Eligibility criteria

• • 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.