Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-03-06 @ 12:26 PM
Study NCT ID:
NCT00993993
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2009-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relational Development in Children With Cleft Lips and Palates: Influence of the Waiting Period Prior to the First Surgical Intervention and the Parents' Psychological Perception of the Abnormality
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P) is multidisciplinary. The careful consideration of concerned families during the repetitive appointments required by these treatments show the importance of the psychological context and of the harmonious structuring of the parents-child relationships on the child's development. Yet the birth of a child affected by CL/P is a particularly stressing and traumatising event for the parents. The investigators' prospective, multidisciplinary and multi-centred research project aims to assess the psychological perceptions of parents of children affected by CL/P over the year following the birth and analyse the child's degree of psychological suffering as well as the parents-child relationships. The time of the first surgical intervention varies amongst the treatment centres. The investigators listed four centres that intervene at different times according to the more or less long waiting times between the child's birth and this first surgical intervention. The results obtained for each group will be compared to one another and according to two sub-groups: parents who found out about the CL/P through embryo diagnosis and those who found out at their child's birth. The mental and psychological dimension due to the malformation and its correction will be analysed in the parents group (importance of the prenatal diagnosis, relational development with the child, self-esteem, quality of life) but also in the child (likely distress and withdrawal symptoms).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: