Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06424392

Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Years - 9 Years

Study Type

OBSERVATIONAL

Enrollment

434

Start Date

2024-12-19

Completion Date

2027-06

Last Updated

2026-03-23

Healthy Volunteers

No

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

Locations (1)

Hôpital Necker Enfants Malades

Paris, France