Clinical trial NCT06848218: Music Therapy During NIV Implantation in Pediatric Intensive Care Units
Official title: Music Therapy During NIV Implantation in Pediatric Intensive Care Units
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Respiratory Failure (ARF)
Non Invasive Ventilation (NIV)
Keywords: Music Therapy
Non invasive Ventilation
Pediatric intensive care unit
Pain
Comfort
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 88
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-center, randomized controlled study, with blinded assessment of primary endpoint.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: Patient admitted to a Pediatric Intensive Care Unit are exposed to moderate to severe pain due to disease severity and invasive treatment or procedures.

Non invasive ventilation is an essential support in the treatment of infants and children with acute respiratory failure. Acceptance and tolerance are the keys to its success.

Comfort management, including pain management, is most often achieved through the administration of analgesic and/or sedative drugs (analgesics, anti-inflammatories, anxiolytics, hypnotics). However, these therapies, although effective, are not without risks, including potentially serious adverse effects (excessive sedation, prolonged hospitalization and ventilation, tolerance phenomena, withdrawal syndrome, delirium, constipation, etc.). These undesirable effects and their deleterious consequences prompt a more comprehensive approach to patient management, optimizing therapeutic strategies with the common aim of improving patient comfort and pain relief. One specific program, "Music Care" is based on a "U sequence" which use tempo and rhythm variations following the U scheme, to relax patients.

This program will be evaluated in the pediatric intensive care department and the investigators will study the effects on the pain level during a non invasive ventilation setting for children with respiratory failure.

the investigators will compare the variation of the FLACC scores (before and during nopn invasive ventilation setting) to show a difference between both methods. The order (with or without) will be randomized.

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.

Primary outcomes:
measure: Pain variation before and during non invasive ventilation setting with and without music therapy.
timeFrame: assessment for 10 minutes before NIV start-up and for 10 minutes during NIV installation
Secondary outcomes:
measure: Pain variation during and after non invasive ventilation setting with and without music therapy. the highest score for each parameter will be selected for each evaluation period of 10 minutes
timeFrame: assessment for 10 minutes during NIV installation and for 10 minutes after NIV start-up
measure: Physiological data variations between the 2 groups: HR
timeFrame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
measure: Physiological data variations between the 2 groups: FR
timeFrame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
measure: Physiological data variations between the 2 groups: SBP
timeFrame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
measure: Physiological data variations between the 2 groups: MAP
timeFrame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
measure: Physiological data variations between the 2 groups: SpO2
timeFrame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
measure: Physiological data variations between the 2 groups: FiO2.
timeFrame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
measure: NIV set-up time between groups
timeFrame: from initiation to completion of NIV installation
measure: Total NIV duration between groups
timeFrame: From initiation of the first NIV to the date of death or discharge from hospital, or up to 1 month after initiation of the NIV at the most
measure: Failure to implement NIV between groups
timeFrame: From initiation of the first NIV to the date of death or discharge from hospital, or up to 1 month after initiation of the NIV at the most
measure: Use of sedative or anxiolytic drugs during NIV implantation between groups
timeFrame: from initiation to completion of NIV installation
measure: Length of stay in intensive care between groups
timeFrame: from the date of admission in intensive care until discharge, or up to 1 month after initiation of NIV
measure: total length of hospital stay between groups
timeFrame: from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV
measure: comparison of the number of NIV-related complications between the 2 groups
timeFrame: from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV
Other outcomes:
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