RecruitingNCT05775679

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


Sponsor

Department of Plastic and Reconstructive Surgery

Enrollment

260 participants

Start Date

Feb 15, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 8 YearsMax Age: 29 Years

Inclusion Criteria3

  • Cleft lip and/or palate
  • Planned secondary surgery of the nose, lips, jaw or to improve speech
  • Can speak and read Swedish

Exclusion Criteria1

  • Multiple surgeries at once

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Locations(1)

Skania University Hospital

Malmö, Skåne County, Sweden

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NCT05775679


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