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Recruiting NCT05775679

Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q

Trial Parameters

Condition Cleft Lip and Palate
Sponsor Department of Plastic and Reconstructive Surgery
Study Type OBSERVATIONAL
Phase N/A
Enrollment 260
Sex ALL
Min Age 8 Years
Max Age 29 Years
Start Date 2022-02-15
Completion 2026-12-31

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Cleft lip and/or palate * Planned secondary surgery of the nose, lips, jaw or to improve speech * Can speak and read Swedish Exclusion Criteria: * Multiple surgeries at once

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