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Study identifier: NCT05775679 Synced from ClinicalTrials.gov · July 28, 2026
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Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q

Condition: Cleft Lip and Palate  ·  Sponsor: Department of Plastic and Reconstructive Surgery

PhaseN/A
Planned participants260
Who can joinAll sexes, 8 Years to 29 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Mia Stiernman, MD PhD  ·  +46737032606  ·  mia.stiernman@med.lu.se

Always discuss trial participation with your own doctor first.

Locations (1)

Skania University HospitalMalmö, Skåne County, SwedenRecruiting

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Source record: clinicaltrials.gov/study/NCT05775679