Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- maternal anxiety level
研究概览
简要总结
The absence of surgery of Congenital lung malformations (CLMs), if it avoids a stressfull event, is accompanied by a "medicalization" of the child, which will be regularly followed up in a specialized medical and surgical environment. The persistent risk of complication, albeit low, is likely to induce over-protective parental behaviours, and to be associated with a sustained family anxiety reaction. The main objective is to test the hypothesis that the absence of surgery has a significant impact on parental anxiety, measurable at 6- 9 years of age.
详细描述
The knowledge of CLMs has been revolutionized by prenatal imaging and the identification of large numbers of CLMs that remain asymptomatic. France is a leader in this field, having set up the only prospective multicentre cohort currently available internationally, with follow-up starting in the prenatal period (MALFPULM). This cohort has already enabled a better description of the prenatal history and the development of an algorithm predictive of the risk of neonatal respiratory distress. The children were followed up to the age of 2 years, and 66% of them were operated on between 0 and 2 years of age. This cohort is a unique opportunity to measure the mid-term impact of this surgical decision, in terms of both medical complications and psychological consequences.
In particular, the size of the cohort makes it possible to answer with a sufficient level of evidence to the following controversies:
- What is the risk of CLM infection in the absence of surgical removal, and is this risk dependent on the CLM phenotype?
- What is the functional respiratory impact of surgical techniques (thoracoscopy or thoracotomy), depending on the age of the surgery?
- What is the prevalence of musculoskeletal complications according to surgical techniques (thoracoscopy or thoracotomy)?
- What is the burden of the medical or surgical follow-up depending on the chosen therapeutic option?
- What is the psychological impact of the surgical decision on the parents and the child? Considering the psychological impact is a major issue for this malformative condition which mainly concerns asymptomatic children, and is of great originality because it has never been evaluated. The most recent literature clearly calls for integrating issues of family well-being and parental mental health into the follow-up of children with chronic disease and/or congenital anomalies. For this reason, the investigators chose maternal anxiety as the main criterion of this study. Specifically for CLM, demonstrating the impact of the investigator's decisions on the psychological state of the parents will be a strong encouragement to integrate this dimension in care, for a better detection of these anxious and/or depressive parental reactions, and a better personalization of the transmission of decisions.
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 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child of the MALFPULM cohort, with their parents
- •At least one follow-up visit between 0 and 2 years of age (n= 414 eligible children)
- •Non-opposition of the family
排除标准
- •Child with CLM, but not included in MALFPULM
- •Parents who participated in MALPULM, but with prenatal fetal death, or neonatal death.
结局指标
主要结局
maternal anxiety level
时间窗: 1 year
The level of maternal anxiety is measured using the GHQ-12 anxiety scale. The GHQ ( General Health Questionnaire) consists of 12 items, each assessing the severity of a mental problem over the past few weeks. Each reponse is scored from 0 to 3, with a total score ranging from 0 to 36. Higher scores indicate poorer health.
次要结局
- Impact of the surgical decision on respiratory morbidity - treatment(1 year)
- Impact of the surgical decision on respiratory morbidity - lower respiratory tract infections(1 year)
- Impact of the surgical decision on respiratory morbidity - hospitalizations(1 year)
- Impact of the surgical decision on respiratory morbidity - severe wheezing respiratory exacerbations(1 year)
- Impact of the surgical decision on respiratory morbidity - lung function tests(1 year)
- Impact of the surgical decision on respiratory morbidity - thoracic deformities(1 year)
- Impact of the surgical decision on respiratory morbidity - burden of the medical or surgical follow-up(1 year)
- Anxiety and depression - GHQ-12(1 year)
- Anxiety and depression - STAI-Y(1 year)
- Anxiety and depression - RCMAS(1 year)
- Quality of life - WHOQOL-BREF(1 year)
- Parenting Sense of Competence questionnaire(1 year)
- Over-protective parental behaviours(1 year)