Music Therapy During NIV Implantation in Pediatric Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Pain variation before and during non invasive ventilation setting with and without music therapy.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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/
- •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.
研究组 & 干预措施
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.
干预措施: Music Therapy (Other)
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.
干预措施: Setting Up NIV (Procedure)
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.
干预措施: Setting Up NIV (Procedure)
结局指标
主要结局
Pain variation before and during non invasive ventilation setting with and without music therapy.
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- NIV set-up time between groups(from initiation to completion of NIV installation)
- 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)
- 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)
- Use of sedative or anxiolytic drugs during NIV implantation between groups(from initiation to completion of NIV installation)
- 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)
- 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)
- 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)