Qualitative and Quantitative Study Which Aims to Determine the Specifics of the Announcement for the Diagnosis of Patients With Craniosynostosis and Their Parents to Better Support Them in Their Care (AmAc)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Craniosynostosis

Treatments: Other: quantitative survey; Other: qualitative survey

Study type: Observational

Funder types: Other

Identifiers

NCT02287805

URC 1073

Details and patient eligibility

About

The purposes of this study are:

• to better understand the experience of the announcement for the diagnostic of craniosynostosis to patients and their families to improve the understanding of it and it modes of appropriation
• to compare the announcement process concerning "simple" and "complex" forms.
• to identify the intra-family issues at the announcement of a genetic mutation.
• to reconstruct the care course of patients by analyzing the time of the announcement and the post-operative period.

Full description

The supported hypothesis is that the diagnosis of craniosynostosis disturbs the initial family pattern. The different forms of the disease will have different repercussions on intra-family relationships.

The quality of the announcement done by the doctor influences the way how the subjects (parents and patients themselves) appropriate and incorporate it at short, medium and long term.

This research will contribute to the knowledge of this rare disease by different scientific communities: social sciences, medicine and neuropsychology. The originality of this research lies in interdisciplinary teams involved and the cross looks between professional and associative fields.

To better understand the impact of congenital malformations and specifically those related to craniosynostosis, the experiences of children and their families at short, medium and long term, the research will take place in the center of reference "Dysostoses craniofacial", Pediatric Neurosurgery Service at the Necker Hospital in Paris.

Prior to fieldwork, a thorough literature search will be conducted on issues related to our subject: the announcement, psychological, identity, family and social impacts, as well as the specifics of the disease and its manifestations.

The fieldwork will be included in a longitudinal approach which will be located at the intersection of quantitative and qualitative methods.

Enrollment: 574 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

Group 1 :

Parents of operated children with a clinical diagnosis of craniosynostosis

Group 2 :

• Parents of newly diagnosed children for a craniosynostosis who will be operated
• Children aged 15 who were operated for a craniosynostosis at least 10 years ago

Group 3 :

• Parents of newly diagnosed children for a craniosynostosis who will be operated
• Children aged 15 who were operated for a craniosynostosis at least 10 years ago

Exclusion Criteria:

• nothing to declare

Trial design

574 participants in 3 patient groups

quantitative survey 1

Description:

parents of 300 patients with craniosynostosis diagnostic

Treatment:

Other: quantitative survey

qualitative survey

Description:

* parents of 12 newly diagnosed patients, they will be seen 3 times (after the diagnosis, 3 months after surgery, 1 year after surgery * 12 patients aged over 15 years, operated more than 10 years before

Treatment:

Other: qualitative survey

quantitative survey 2

Description:

* 100 parents of patients 1 year after surgery * 100 parents of patients, 5 years after the operation * 100 patients aged over 15 years and operated over 10 years ago

Treatment:

Other: quantitative survey