Actively Recruiting

Age: 8Years - 29Years
All Genders
Healthy Volunteers
NCT05775679

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

Led by Department of Plastic and Reconstructive Surgery · Updated on 2023-03-20

260

Participants Needed

1

Research Sites

358 weeks

Total Duration

On this page

Sponsors

D

Department of Plastic and Reconstructive Surgery

Lead Sponsor

K

Karolinska University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years - 29Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Has cleft lip and/or palate
  • Planned for secondary surgery of the nose, lips, jaw, or to improve speech
  • Can speak and read Swedish
Not Eligible

You will not qualify if you...

  • Undergoing multiple surgeries at the same time

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Skania University Hospital

Malmö, Skåne County, Sweden

Actively Recruiting

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Research Team

M

Mia Stiernman, MD PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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