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

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying General Health Questionnaire (GHQ-12), Parental Educational Competence Self-Evaluation Questionnaire "Questionnaire d'Auto-Évaluation de la Compétence Éducative Parentale (QAECEP)", and others for people with congenital lung malformations. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Years to 9 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06424392