Music Therapy During NIV Implantation in Pediatric Intensive Care Units (MusiNIV)

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).

Study Overview

• Status: Recruiting
• Conditions: Non Invasive Ventilation (NIV); Acute Respiratory Failure (ARF)
• Intervention / Treatment: Other: Music Therapy; Procedure: Setting Up NIV

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie MOUNIER, MD; Phone Number: +33 04 67 33 66 09; Email: s-mounier@chu-montpellier.fr
• Study Contact Backup: Name: Christophe MILESI, MD; Phone Number: +33 04 67 336158; Email: c-milesi@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34090
    • Recruiting
    • CHU de Montpellier
    • Contact: Email: s-mounier@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non invasive ventilation setting with Music Therapy; Each child will benefit non invasive ventilation setting for acute respiratory distress. In this group, it will be with Music Therapy. Every time, the preparation will be the same with equipment installation with headphones for music listening, in order to keep comparability and blind for the evaluation. Sound will be activated in this group. Each child will be videotaped during the non invasive ventilation setting.	Other: Music Therapy; This procedure is carried out using headphones installed in the child's ears. The music will be activated if the child is in the Music group, and will not be activated but present if the child is not in the Music group. NIV implementation will begin after 10 min of listening. The listening period will continue until the nadir period (when the music is slowest, for maximum relaxation), until 10 min after the start of the NIV.; Procedure: Setting Up NIV; Non invasive ventilation is set up in several stages, with the help of at least two caregivers. The patient will be placed in a half-seated position or seated. Installation begins with the placement of the non invasive ventilation mask harness around the child's head, followed by the application of the mask to the face, held by a caregiver. Once the mask has been applied, ventilation is started by connecting the non invasive ventilation circuit to the mask. The harness is then tightened by the second caregiver.
Sham Comparator: Non invasive ventilation setting without Music Therapy; Each child will benefit Non invasive ventilation setting for acute respiratory distress. In this group, it will be without Music therapy. Every time, the preparation will be the same with equipment installation with headphones for music listening, in order to keep comparability and blind for the evaluation. Sound will not be activated in this group. Each child will be videotaped during the non invasive ventilation setting.	Procedure: Setting Up NIV; Non invasive ventilation is set up in several stages, with the help of at least two caregivers. The patient will be placed in a half-seated position or seated. Installation begins with the placement of the non invasive ventilation mask harness around the child's head, followed by the application of the mask to the face, held by a caregiver. Once the mask has been applied, ventilation is started by connecting the non invasive ventilation circuit to the mask. The harness is then tightened by the second caregiver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain variation before and during non invasive ventilation setting with and without music therapy.	FLACC (Face Legs Activity Cry Consolability) : The main assessment tool is a simple, rapid behavioral pain assessment scale, commonly used in the pediatric intensive care unit. For each item, 3 possible scores: 0 or 1 or 2; the total score is from 0 (no pain) to 10 (severe pain). The primary outcome is variation of the Face Legs Activity Cry Consolability (FLACC) score (range, 0-10) comparing before and during non invasive ventilation setting. The first FLACC score evaluation will be just before the beginning of music. The Second FLACC score evaluation will be during the non invasive ventilation setting. FLACC score evaluation over a 10-minute period, with selection of the highest score for each item during the evaluation period FLACC scores' evaluation will be done from videotape records without by 2 investigators The FLACC score will be determined blindly by two assessors who did not participate in the care, using the video taken when the NIV was set up.	assessment for 10 minutes before NIV start-up and for 10 minutes during NIV installation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	FLACC (Face Legs Activity Cry Consolability) : The main assessment tool is a simple, rapid behavioral pain assessment scale, commonly used in the pediatric intensive care unit. For each item, 3 possible scores: 0 or 1 or 2; the total score is from 0 (no pain) to 10 (severe pain). The primary outcome is variation of the Face Legs Activity Cry Consolability (FLACC) score (range, 0-10) comparing before and during non invasive ventilation setting. The first FLACC score evaluation will be just before the beginning of music. The Second FLACC score evaluation will be during the non invasive ventilation setting. FLACC scores' evaluation will be done from videotape records without by 2 investigators The FLACC score will be determined blindly by two assessors who did not participate in the care, using the video taken when the NIV was set up.	assessment for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: HR	An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards. HR: heart rate in beats per minute the highest score for each parameter will be selected for each evaluation period of 10 minutes	assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: FR	An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards. FR: respiratory rate in inhalations per minute the highest score for each parameter will be selected for each evaluation period of 10 minutes	assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: SBP	An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards. SBP: systolic blood pressure in millimeters of mercury mmHg the highest score for each parameter will be selected for each evaluation period of 10 minutes	assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: MAP	An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards. MAP: mean arterial pressure in millimetres of mercury mmHg the highest score for each parameter will be selected for each evaluation period of 10 minutes	assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: SpO2	An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards. SpO² : blood oxygen saturation in percent the highest score for each parameter will be selected for each evaluation period of 10 minutes	assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: FiO2.	An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards. FiO2: fraction of inspired oxygen in percent the highest score for each parameter will be selected for each evaluation period of 10 minutes	assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
NIV set-up time between groups	time from initiation to completion of NIV installation in minutes	from initiation to completion of NIV installation
Total NIV duration between groups	in hours	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
Failure to implement NIV between groups	in raw numbers	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
Use of sedative or anxiolytic drugs during NIV implantation between groups	dose in μg/kg/h	from initiation to completion of NIV installation
Length of stay in intensive care between groups	in days	from the date of admission in intensive care until discharge, or up to 1 month after initiation of NIV
total length of hospital stay between groups	in days	from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV
comparison of the number of NIV-related complications between the 2 groups	Number of Complications of NIV, e.g. pneumothorax, decreased cardiac output (hypotension), gastric and abdominal distension, inhalation, nose, face and scalp pressure points, non-compliance, eye irritation	from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Music Therapy; Comfort; Pediatric intensive care unit; Non invasive Ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: RECHMPL23_0191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No