Multidimensional Characterization of Dyspnea in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Validate the Multidimensional Dyspnea Profale (MDP) self-evaluation scale in children aged between 12 and 17 years presenting with acute or chronic dyspnea.
研究概览
简要总结
There is no specific tool existing to describe dyspnea in children in a multidimensional way.
It has been shown in adult studies that multidimensional dyspnea evaluation scales are well correlated to quality of life and respiratory function impairments.
The investigators hypothesis is that using multidimensional dyspnea evaluation scales could allow for a more systematic and precise evaluation of this symptom in children, thus improving management and follow-up of patients presenting with acute (asthma attack, infectious diseases) and chronic (cystic fibrosis, primary ciliary diskynesia, neuromuscular diseases) respiratory insufficiency.
详细描述
Introduction Breathing is most of the time an activity realized ion an automated way. In various situations however, it can be "felt", for example when people are producing an effort. To term used to refer to these situation is "breathlessness". When breathing is perceived as an unpleasant sensation, causing suffering, especially in the context of diseases that are often of cardiac or respiratory origin, the appropriate term is "dyspnea".
In 1999, a consensus conference defined dyspnea as a subjective experience of respiratory discomfort consisting in sensations of distinct quality and varying intensity.
Sensory and emotional aspects associated to dyspnea have been compared to those observed in pain. Pain is often defined according to its intensity, quality and temporal evolution of its sensory dimension, but also according to the emotional response it induces. There are similarities between pain and dyspnea, two unpleasant sensations sharing common physiological substrates. Two studies have previously demonstrated that there is an overlap between cerebral regions activated during pain and those activated when dyspnea occurs. This is in favor of analyzing dyspnea according to the same sensory and emotional dimensions as pain.
To those intrinsic sensory characteristics are added psychological, social and economic factors that may have an influence, positively or negatively, on the sensation of dyspnea.
Scientific background Dyspnea is multifactorial and multidimensional. Its multidimensional nature can be apprehended using specific tools and questionnaires designed to this effect. Among them, the Dyspnoea-12, the Multidimensional Dyspnea Profile (MDP) ans the Respiratory Distress Observation Scale (RDOS). These scales take into account not only the intensity of dyspnea, but also its sensory qualities and affective dimension, which can vary independently from one another. All these scales have already been validated in French language.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 6-17 years old at inclusion
- •Experiencing respiratory complaints at inclusion
- •Social security number
- •Children whom parents or legal representatives are present or reachable via phone call at inclusion
- •Non-opposition of parents or legal representatives to participate in the study
- •Children who are followed at or hospitalized in Trousseau hospital's pediatric pulmonology department for: asthma attack, acute respiratory insufficiency, acute exacerbation of a chronic respiratory disease, chronic respiratory insufficiency.
- •For the study of acute dyspnea: patients hospitalized for acute respiratory disease since less than 72h.
- •For the study of chronic dyspnea: children presenting with chronic respiratory disease.
排除标准
- •Cognitive disorders making it impossible to understand self-assessment scales
- •Refusal of the child to participate in the research
- •For the assessment of chronic dyspnea:
- •Children followed for a chronic respiratory pathology having presented an episode of acute respiratory decompensation in the 6 weeks preceding inclusion.
结局指标
主要结局
Validate the Multidimensional Dyspnea Profale (MDP) self-evaluation scale in children aged between 12 and 17 years presenting with acute or chronic dyspnea.
时间窗: through study completion, an average of 36 months
Use of the MDP questionnaire and test if usable and compliant for the teenager. (Scale from 0 to 10, with 10 corresponding to significant breathing difficulties.)
次要结局
- Provide a multidimensional description of dyspnea using the MDP scale in children aged 12-17 y/o.(through study completion, an average of 36 months)
- Validate the use of a simplified MDP in children aged between 6-11 y/o presenting with acute or chronic dyspnea.(through study completion, an average of 36 months)
- Study the impact of dyspnea on quality of life using the PedSQL scale in children presenting with chronic dyspnea and their families.(through study completion, an average of 36 months)
- Validate the Respiratory Distress Observation Scale (RDOS) hetero-evaluation scale in patients aged between 12-17 years presenting with acute dyspnea.(through study completion, an average of 36 months)
- Study the association between dyspnea scores and different clinical features, the use of treatments and results of explorations(through study completion, an average of 36 months)
- Study the correlation between MDP and RDOS scores and Dyspnea-visual analogue scale (VAS).(through study completion, an average of 36 months)
- Provide a multidimensional description of dyspnea in children aged between 6-11 y/o.(through study completion, an average of 36 months)
- Study the correlation between the simplified MDP and the dyspnea-VAS.(through study completion, an average of 36 months)
- Study the correlation between dyspnea scores in children and their parents' anxity scores using the State-Trait Anxiety Inventory (STAI-Y) questionnaire.(through study completion, an average of 36 months)