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 "

• Conditions: Atresia, Esophageal
• Interventions: Other: Questionnaires

• Registration Number: NCT04911036
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-06
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mothers and/or fathers with an antenatal diagnosis	Questionnaires	-
Mothers and/or fathers with a postnatal diagnosis	Questionnaires	-

Primary Outcome Measures

Name	Time	Method
Perinatal Posttraumatic Stress Disorder Questionnaire (score PPQ)	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)

Secondary Outcome Measures

Name	Time	Method
Percentage of mothers with Score PPQ >5	at 2 months
Questionnaire on early support	at 2 months	This is a questionnaire co-constructed with the Association Française de l'Atresie de l'œsophage (AFAO) to collect information on the perception of support available or received upon suspicion of an abnormality in the child. It consists of 15 questions. The first eight explore satisfaction with various aspects of early support (information, support, professionals met...). The next seven address parental perceptions regarding information and support. Most of the questions are to be answered on a 5-point Likert scale (e.g., from "Not at all satisfied" to "Very satisfied" or "Never" to "Almost always"), the other questions are closed-ended. Time to complete the test: 5 to 10 minutes.
Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to mothers	at 2 months	State-Trait Anxiety Inventory (STAI-TRAIT) SCORE: 20 items in the form of a 4-response Likert scale (from 1 : low anxiety to 4 : highest anxiety). The score goes from 20 to 80 depending of the degree of anxiety.
Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to fathers	at 2 months

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France