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 "
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires.
- Who it may be relevant to
- Registry conditions: Atresia, Esophageal. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Questionnaires
Perinatal PTSD Questionnaire State Trait Anxiety Inventory-forme Y-B Early Support Questionnaire Socio-demographic questionnaire
Primary outcome measures
- Perinatal Posttraumatic Stress Disorder Questionnaire (score PPQ) [Time frame: at 2 months]
Secondary outcome measures (4)
- Percentage of mothers with Score PPQ >5 [Time frame: at 2 months]
- Questionnaire on early support [Time frame: at 2 months]
- Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to mothers [Time frame: at 2 months]
- Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to fathers [Time frame: at 2 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hop Jeanne de Flandre Chu Lille — Lille
Identifiers
NCT: NCT04911036 · 2019_26 · 2020-A00255-34