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Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations

NCT06424392 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 434

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Congenital Lung Malformations

Interventions

OTHER

General Health Questionnaire (GHQ-12)

Anxiety and depression self-reported scales for both parents

OTHER

State-Trait Anxiety Inventory (STAI-Y)

Anxiety and depression self-reported scales for both parents

OTHER

Revised Children's Manifest Anxiety Scale (RCMAS)

Anxiety and depression self-reported scales for children

OTHER

World Health Organization Quality of Life (WHOQOL-BREF)

Quality of life self-reported scales for parents

OTHER

Parental 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

OTHER

Parental 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

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Christophe DELACOURT · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
6 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06424392 on ClinicalTrials.gov