Evaluating the CLEFT-Q questionnaire for patients with cleft lip and palate
Official title: Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q
Run by Department of Plastic and Reconstructive Surgery · NCT05775679 · Data updated 2026-11-12
This study is testing a questionnaire called CLEFT-Q to see how well it works for people with cleft lip and palate in tracking their health and changes after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 8 Years to 29 Years |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | Department of Plastic and Reconstructive Surgery Research network |
| Locations | 1 site (Malmö, Skåne County) |
| Status | Recruiting |
| Started | February 15, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2028 |
| Registry record updated | March 20, 2023 |
| Trial ID | NCT05775679 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with cleft lip and/or palate who are planning secondary surgeries and can communicate in Swedish.
✕Probably not a fit
Patients undergoing multiple surgeries at once may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the reliability and responsiveness of the CLEFT-Q questionnaire in patients with cleft lip and/or palate. It will evaluate whether CLEFT-Q scores remain consistent over time and can detect changes following surgical interventions. Additionally, the study seeks to establish normative data for CLEFT-Q in a control population and identify the Minimal Clinically Important Change across different subpopulations. The research will also explore patient expectations and perceptions regarding surgical outcomes and the impact of CLEFT-Q on clinical decision-making.
Why it matters
Potential benefit: If successful, this study could enhance the assessment of patient-reported outcomes in cleft lip and palate surgeries, leading to improved patient care.
How similar studies have gone: While the specific application of CLEFT-Q is being evaluated here, similar psychometric assessments have shown promise in other patient populations, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Skania University Hospital
Malmö, Skåne County, Sweden Recruiting
Study contacts
- Principal investigator: Mia Stiernman, MD PhD — Mia Stiernman
- Study coordinator: Mia Stiernman, MD PhD
- Email: mia.stiernman@med.lu.se
- Phone: +46737032606
Similar studies
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This study is testing whether doing all the necessary nose and gum repairs in one surgery is better than spreading them out over multiple surgeries for kids with cleft lip and palate.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.