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RecruitingNCT06424392

Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

434 participants

Start Date

Dec 19, 2024

Study Type

OBSERVATIONAL

Conditions

Congenital Lung Malformations

Summary

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.

Eligibility

Min Age: 6 YearsMax Age: 9 Years

Inclusion Criteria3

  • 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

Exclusion Criteria2

  • Child with CLM, but not included in MALFPULM
  • Parents who participated in MALPULM, but with prenatal fetal death, or neonatal death.
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Interventions

OTHERGeneral Health Questionnaire (GHQ-12)

Anxiety and depression self-reported scales for both parents

OTHERState-Trait Anxiety Inventory (STAI-Y)

Anxiety and depression self-reported scales for both parents

OTHERRevised Children's Manifest Anxiety Scale (RCMAS)

Anxiety and depression self-reported scales for children

OTHERWorld Health Organization Quality of Life (WHOQOL-BREF)

Quality of life self-reported scales for parents

OTHERParental Educational Competence Self-Evaluation Questionnaire "Questionnaire d'Auto-Évaluation de la Compétence Éducative Parentale (QAECEP)"

Parental Educational Competence Self-Evaluation self-reported Questionnaire for parents

OTHERParental interview

The interview will only last about ten minutes and will take place during the first call, if the parents have agreed and are sufficiently available to answer. If the parents are not available, an appointment can be made at a later date

Locations(1)

Hôpital Necker Enfants Malades

Paris, France

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NCT06424392