Clinical trial Recruiting at 1 site Observational Ages 8 to 29

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 typeObservational
Ages8 Years to 29 Years
SexAll
Enrollment260 (estimated)
SponsorDepartment of Plastic and Reconstructive Surgery
Research network
Locations1 site (Malmö, Skåne County)
StatusRecruiting
StartedFebruary 15, 2022
Main results expectedDecember 31, 2026
Study endsDecember 31, 2028
Registry record updatedMarch 20, 2023
Trial IDNCT05775679 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.