Music Therapy During NIV Implantation in Pediatric Intensive Care Units

NCT06848218 | Recruiting

• 1 other identifier: RECHMPL23_0191
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Music Therapy; Non invasive Ventilation; Pediatric intensive care unit; Pain; Comfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

  assessment for 10 minutes during NIV installation and for 10 minutes after NIV start-up

• Physiological data variations between the 2 groups: HR

  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

  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

  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

  assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up

Study Arms (2)

Non invasive ventilation setting with Music Therapy

EXPERIMENTAL

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; Procedure: Setting Up NIV

Non invasive ventilation setting without Music Therapy

SHAM COMPARATOR

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

Interventions

Music Therapy 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.

Non invasive ventilation setting with Music Therapy

Setting Up NIV 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 with Music Therapy; Non invasive ventilation setting without Music Therapy

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 0 to 17 inclusive
• Children hospitalized in pediatric intensive care unit
• Indication for NIV

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de MONTPELLIER

Montpellier, 34090, France

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Sophie MOUNIER, MD

CONTACT

04 67 33 66 09; s-mounier@chu-montpellier.fr

Christophe MILESI, MD

CONTACT

04 67 336158; c-milesi@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the primary endpoint (FLACC Score) will be assessed on patient videos taken during NIV initiation. Thus, 2 FLACC score assessors will be blinded to the randomization arm
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, randomized controlled study, with blinded assessment of primary endpoint.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 26, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

FR (1)