Music Therapy During NIV Implantation in Pediatric Intensive Care Units
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Music Therapy, Setting Up NIV.
- Кому может быть актуально
- Состояния в реестре: Acute Respiratory Failure (ARF), Non Invasive Ventilation (NIV). Базовые параметры: до 17 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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).
Подробное описание
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.
Вмешательства
- Другое 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. - Процедура 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 s
Первичные конечные точки
- Pain variation before and during non invasive ventilation setting with and without music therapy. [Срок оценки: assessment for 10 minutes before NIV start-up and for 10 minutes during NIV installation]
Вторичные конечные точки (12)
- 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 [Срок оценки: assessment for 10 minutes during NIV installation and for 10 minutes after NIV start-up]
- Physiological data variations between the 2 groups: HR [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: from initiation to completion of NIV installation]
- Total NIV duration between groups [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: from initiation to completion of NIV installation]
- Length of stay in intensive care between groups [Срок оценки: from the date of admission in intensive care until discharge, or up to 1 month after initiation of NIV]
Критерии участия
Target population : Children aged 0 to 17, hospitalized in the pediatric intensive care unit for respiratory failure with indication for NIV.
Критерии включения
- Children aged 0 to 17 inclusive
- Children hospitalized in pediatric intensive care unit
- Indication for NIV
Критерии исключения
- \- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Франция · 1 центр
- CHU de MONTPELLIER — Montpellier
Идентификаторы
NCT: NCT06848218 · RECHMPL23_0191