Music therapy to ease pain during noninvasive ventilation in children
Music Therapy During NIV Implantation in Pediatric Intensive Care Units
This trial will try using a structured music program to lower pain and improve comfort for children (0–17) who are starting noninvasive ventilation in the pediatric intensive care unit.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06848218 on ClinicalTrials.gov |
What this trial studies
Children admitted to a pediatric intensive care unit with acute respiratory failure who need noninvasive ventilation will be randomized to receive either standard care or standard care plus a structured "Music Care" program during NIV initiation. Pain will be measured using the FLACC score immediately before and during NIV by raters blinded to group assignment. The Music Care program uses a tempo-and-rhythm "U sequence" designed to induce relaxation. The study compares change in FLACC scores between the music and control groups to see if music reduces procedural pain and improves tolerance of NIV.
Who should consider this trial
Good fit: Ideal candidates are children aged 0–17 hospitalized in the pediatric intensive care unit for acute respiratory failure with a planned start of noninvasive ventilation who can be scored with the FLACC tool and whose guardians provide consent.
Not a fit: Children with severe deafness, those requiring immediate unplanned NIV initiation, those who cannot be assessed with FLACC (for example due to paralysis), or those already on home NIV are unlikely to benefit from this intervention in the trial.
Why it matters
Potential benefit: If successful, the intervention could reduce pain and the need for sedative or analgesic drugs during NIV, improving comfort and NIV acceptance in critically ill children.
How similar studies have performed: Music-based interventions have shown benefit for pain and anxiety in pediatric and critical care settings, but applying a structured music program specifically during pediatric NIV initiation is relatively novel and not well studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montpellier
- CHU de MONTPELLIER — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Sophie MOUNIER, MD
- Email: s-mounier@chu-montpellier.fr
- Phone: 04 67 33 66 09
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.