Skania University Hospital
Malmö, Skåne County, Sweden
Location status: Recruiting
NCT Number: NCT05775679
The goal of this observational study is to test the questionnaire CLEFT-Q in a population of patients with cleft lip and/or palate. The main questions it aims to answer are:
1. Are CLEFT-Q scores reliable over time? 2. Can CLEFT-Q detect change following surgical treatment intervention? 3. What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate? 4. What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate? 5. Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention? 6. What are the main expectations that patients express before a surgical intervention? 7. How do patients perceive that the results after surgical interventions meet their expectations? 8. Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q? 9. How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?
Participants will
1. Fill out the questionnaire CLEFT-Q twice with a two-week space. 2. Before and 1 year after an operation. 3. Be interviewed about their experiences related to an operation or using CLEFT-Q.
Researchers will compare results from the cleft lip and palate population to see if there is a difference between them and a population without cleft lip and palate.
Interested in participating?
Request Info8 year–29 year
All sexes
Observational
Malmö, Skåne County, Sweden
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At enrollment and after 1-2 weeks, or after 6 months, or after 1 year.
CLEFT-Q is a questionnaire on health related quality of life specific to patients with cleft lip and palate
Time frame: Before surgery and after 6 months or 1 year.
Photographs from before and after surgery
Time frame: Before surgery and after 1 year.
Recording of speech
Contact information is provided by the study sponsor or research team.
Department of Plastic and Reconstructive Surgery
Network
Acronym: CLEFT-QSwePsyc
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03065686
Cleft Lip, Cleft Lip and Palate
Amiens, France
View Trial DetailsNCT04234971
Cleft Lip, Cleft Lip and Palate
Houston, Texas, United States
View Trial DetailsNCT04771156
Cleft Lip, Cleft Lip and Palate
Houston, Texas, United States
View Trial DetailsNCT07340008
Alveolar Ridge Defect, Cleft Lip
Ljubljana, Slovenia
View Trial Details