Music Therapy During NIV Implantation in Pediatric Intensive Care Units

NCT ID: NCT06848218

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-18
• Study Completion Date: 2027-04-01

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.

Conditions

Acute Respiratory Failure (ARF); Non Invasive Ventilation (NIV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: OTHER

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.

Setting Up NIV

Intervention Type: PROCEDURE

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.

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.

Group Type: SHAM_COMPARATOR

Setting Up NIV

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de MONTPELLIER

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sophie MOUNIER, MD

Role: CONTACT

s-mounier@chu-montpellier.fr

04 67 33 66 09 ext. +33

Christophe MILESI, MD

Role: CONTACT

c-milesi@chu-montpellier.fr

04 67 336158 ext. +33

Facility Contacts

Role: primary

s-mounier@chu-montpellier.fr

Other Identifiers

RECHMPL23_0191

Identifier Type: -

Identifier Source: org_study_id