Actively Recruiting
Music Therapy During Non-Invasive Ventilation Implantation in Pediatric Intensive Care Units
Led by University Hospital, Montpellier · Updated on 2025-07-01
88
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of music therapy on pain levels during non-invasive ventilation (NIV) in critically ill children with acute respiratory failure. The study focuses on pediatric patients in intensive care, comparing pain scores to understand if music can improve comfort during NIV, a key respiratory support technique. Pain is measured using the Face Legs Activity Cry Consolability (FLACC) score by raters who do not know the treatment group to ensure unbiased results. Participants will receive NIV for acute respiratory distress and be randomly assigned to one of two groups: one with music therapy and one without. In the music therapy group, children listen to music through headphones during NIV setup, beginning 10 minutes before NIV starts and continuing during the procedure. In the control group, headphones are worn but music is not played. Both groups are videotaped during NIV installation. Throughout the study, children’s pain levels, physiological data such as heart rate and oxygen levels, and NIV setup times will be monitored before, during, and after NIV initiation. The main outcome is the change in pain scores during NIV. Other measures include duration of NIV use, sedation drug use, complications, and length of hospital stay. Data collection occurs over the course of NIV treatment and up to one month after initiation, with close monitoring to assess the impact of music therapy on comfort and clinical outcomes.
CONDITIONS
Brief 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 pediatric intensive care unit
- Indication for non-invasive ventilation (NIV)
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 high-risk or drug trials
- No affiliation to French social security scheme
- Subject deprived of liberty
- Failure to obtain free and informed consent and authorization for photography from parents or legal guardian
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 20 minutes per session
Participants undergo non invasive ventilation (NIV) setup, which involves placement and adjustment of the NIV mask and equipment. For those in the music therapy group, music is played through headphones starting 10 minutes before NIV setup and continuing until 10 minutes after NIV starts, aiming to improve comfort and reduce pain.
1 in-person session during NIV setup
Duration - Up to 1 month after NIV initiation
After NIV setup, participants are observed for pain levels, physiological data, and the use of sedative or anxiolytic drugs. This period includes monitoring NIV duration, complications, and length of stay in intensive care and hospital.
Ongoing monitoring during hospital stay
Trial Site Locations
Total: 1 location
1
CHU de MONTPELLIER
Montpellier, France, 34090
Actively Recruiting
Research Team
S
Sophie MOUNIER, MD
C
Christophe MILESI, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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