The Financial and Emotional Impact of Cleft Palate

Recruiting

• Conditions: Cleft Lip and Cleft Palate

• Registration Number: NCT06905678
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Cleft lip and/or palate (CL±P) is the most prevalent congenital craniofacial defect with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. WHO highlights the significant financial costs, including morbidity, healthcare costs, emotional distress and social exclusion to patients, their families and society. The purpose of this study is to investigate the financial and emotional impact of CL±P based on the perceptions of children with CL±P and their parents/guardians followed by the interdisciplinary craniofacial teams of the University Hospitals of Leuven or Ghent. Participation in this study consists of completing questionnaires related to financial, social and well-being aspects using the CLEFT-Q, Parental Stress Scale and a financial impact questionnaire. The parents/guardians of the children aged 5 years always complete all questionnaires. The parents/guardians of the 12- and 18-year-old children complete the Parental Stress Scale and a financial impact questionnaire. The children aged 18 complete the CLEFT-Q themselves. Questionnaires can be delivered online or on paper. The outcomes on the health-related QoL of children with cleft and the PSS are compared with the outcomes of 'healthy' children and their parents/guardians to ensure that the emotional impact is attributable to the cleft. In addition, children and their parents/guardians can participate in a semi-structured interview. During the interview appointment, the questionnaires can be completed on paper. Potential participants will be told that the interview will be recorded and that all findings will be kept confidential. The actual interviews will take place at a location and time that is most convenient for the participants. Participants do not need to come to UZ Gent or UZ Leuven for this. Each interview will be recorded with a Roland R-05 high quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographic data. In addition, data regarding the type of cleft, diagnoses, observation sheets and consultation letters will be collected from the medical records of the children with CL±P. We also aim to investigate whether variations in these effects are observable based on the specific type of cleft. All participants will go through the same protocol regardless of recruitment through UZ Gent or UZ Leuven.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-28
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Presence of a cleft (lip and) palate
• Age of 5, 12 or 18 years

Exclusion Criteria

• No specific exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Financial burden of a cleft	2 months	The parents of children with a cleft will fill in a questionnaire regarding the costs of having a child with a cleft. Using this information and de electronic patient record the investigators can calculate the estimated cost of having a child with a cleft.
Emotional burden of a cleft	2 months	Using questionnaires the emotional burden of a cleft will be examined. The parents of the children with a cleft will fill in the Parental Stress Scale (18 items that evaluate parents' feelings about their parental role, with both positive and negative aspects of parenting), and the children with a cleft will fill in the CLEFT-Q (a comprehensive Patient-Reported Outcome Measure (PROM) evaluating QoL, facial function and assessment of appearance).

Secondary Outcome Measures

Name	Time	Method
Differences in impact based on the type of cleft	Through study completion, an average of 1 year	The investigators want to examine if the results on the questionnaire will be different based on the type of cleft. Participants filled in the questionnaires on which type of cleft they have. The results are then reviewed and compared to see if the results obtained depend on the type of cleft.
Does the impact decrease as the child gets older	Through study completion, an average of 1 year	The investigators want to examine if the financial and emotional burden decreases as the child gets older by comparing the financial and emotional impact of the different ages of children/young adults included. For this purpose, the results on the questionnaires of the 3 age groups will be compared.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium