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NCT Number: NCT05775679

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

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.

Recruiting

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Key information

Age range

8 year–29 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Skania University Hospital

Malmö, Skåne County, Sweden

Location status: Recruiting

Location contact

Mia Stiernman, MD PhD

CONTACT

[email protected]

+46737032606

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. CLEFT-Q change scores

    Time frame: At enrollment and after 1-2 weeks, or after 6 months, or after 1 year.

    CLEFT-Q is a questionnaire on health related quality of life specific to patients with cleft lip and palate

Secondary outcomes

  1. Photograph

    Time frame: Before surgery and after 6 months or 1 year.

    Photographs from before and after surgery

  2. Speech

    Time frame: Before surgery and after 1 year.

    Recording of speech

Study contacts

Contact information is provided by the study sponsor or research team.

Mia Stiernman, MD PhD

CONTACT

[email protected]

+46737032606

Sponsors and collaborators

Lead sponsor

Department of Plastic and Reconstructive Surgery

Network

Collaborators

  • Karolinska University Hospital
  • Linköping Univeristy Hospital
  • University Hospital, Umeå
  • Uppsala University Hospital

Registry information

Acronym: CLEFT-QSwePsyc

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Mar 20, 2023
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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