Music Therapy During NIV Implantation in Pediatric Intensive Care Units

Not Applicable

Not yet recruiting

• Conditions: Acute Respiratory Failure (ARF); Non Invasive Ventilation (NIV)

• Registration Number: NCT06848218
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-26
• Study Start: 2027-03-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain variation before and during non invasive ventilation setting with and without music therapy.	assessment for 10 minutes before NIV start-up and for 10 minutes during NIV installation	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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
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	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
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	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
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	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
Physiological data variations between the 2 groups: SpO2	assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up	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
Physiological data variations between the 2 groups: FiO2.	assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up	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
NIV set-up time between groups	from initiation to completion of NIV installation	time from initiation to completion of NIV installation in minutes
Total NIV duration between groups	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	in hours
Failure to implement NIV between groups	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	in raw numbers
Use of sedative or anxiolytic drugs during NIV implantation between groups	from initiation to completion of NIV installation	dose in μg/kg/h
Length of stay in intensive care between groups	from the date of admission in intensive care until discharge, or up to 1 month after initiation of NIV	in days
total length of hospital stay between groups	from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV	in days
comparison of the number of NIV-related complications between the 2 groups	from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV	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