Actively Recruiting
Music Therapy During NIV Implantation in Pediatric Intensive Care Units
Led by University Hospital, Montpellier · Updated on 2025-07-01
88
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Music Therapy During NIV Implantation in Pediatric Intensive Care Units
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 0 to 17 inclusive
- Hospitalized in a pediatric intensive care unit
- Indicated for non-invasive ventilation (NIV) for respiratory failure
You will not qualify if you...
- Severe deafness
- Clinical condition requiring immediate initiation of NIV
- Refusal to allow the child to be photographed
- Child not assessable by FLACC score (e.g., paralysis of lower limbs)
- Child already receiving NIV respiratory support at home
- Participation in other ongoing high-risk or drug research
- No affiliation to a French social security scheme or beneficiary
- Subject deprived of liberty
- Failure to obtain free and informed written or oral consent and authorization for photographs from parents or legal guardian
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU de MONTPELLIER
Montpellier, France, 34090
Actively Recruiting
Research Team
S
Sophie MOUNIER, MD
CONTACT
C
Christophe MILESI, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here