NCT04911036招募中不适用
Study of the Effect of the Time of Diagnosis (Antenatal vs. Postnatal) on the Post-traumatic Reactions of Parents of Children Undergoing Oesophageal Atresia Surgery "
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年5月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Perinatal Posttraumatic Stress Disorder Questionnaire (score PPQ)
研究概览
简要总结
This is an observational, national multicentre (34 centres involved), cross-sectional study in psychology whose objective is to describe and compare the levels of post-traumatic reactions of mothers to the announcement of their child's EA diagnosis.
An ancillary study will be carried out among the fathers present who agree to participate in the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be the mother and/or a father of a living child aged 12 to 24 months who has undergone neonatal surgery following the diagnosis of type 1 or type 3 EA;
- •Not to have objected to participating in the study (information and non-objection form signed by the investigator);
- •To be socially insured.
排除标准
- •Woman or man whose child with AO has a chromosomal abnormality;
- •Woman or man whose child with AO has a polymalformative syndrome;
- •Female or male minor ;
- •Pregnant woman;
- •Woman or man who does not speak French;
- •Woman or man unable to consent, or benefiting from a legal protection regime (guardianship or curatorship);
- •Woman or man deprived of liberty.
结局指标
主要结局
Perinatal Posttraumatic Stress Disorder Questionnaire (score PPQ)
时间窗: at 2 months
The score PPQ derived from this instrument corresponds to the number of items (there are 14) to which the parent responded positively (theoretical spread: 0-14 points)
次要结局
- Percentage of mothers with Score PPQ >5(at 2 months)
- Questionnaire on early support(at 2 months)
- Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to mothers(at 2 months)
- Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to fathers(at 2 months)
研究者
研究点 (1)
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