Music Therapy During NIV Implantation in Pediatric Intensive Care Units
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorUniversity Hospital, Montpellier
About this trial
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).
Eligibility criteria
Qualifiers
Children aged 0 to 17 inclusive
Children hospitalized in pediatric intensive care unit
Indication for NIV
Disqualifiers
- 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.)
Trial design
Treatments tested in this trial
- Music Therapy
- Setting Up NIV
Treatment groups
88 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov