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RecruitingNCT07344649

Turkish Validation of the Nijmegen Questionnaire in COPD

Status
Recruiting
Phase
Study type
Observational
Enrollment
90 (estimated)
Sponsor
Saglik Bilimleri Universitesi · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Dysfunctional breathing is a common and clinically relevant problem in patients with chronic obstructive pulmonary disease (COPD), contributing to increased dyspnea perception, reduced exercise tolerance, and impaired quality of life. The Nijmegen Questionnaire (NQ) is a widely used symptom-based instrument for screening dysfunctional breathing; however, a validated Turkish version for patients with COPD is currently unavailable. This observational methodological study aims to translate, culturally adapt, and evaluate the validity and reliability of the Turkish version of the Nijmegen Questionnaire (NQ-TR) in individuals with stable COPD.

Detailed description

This single-center observational study will be conducted in patients with clinically stable COPD. The study consists of two main phases: (1) translation and cultural adaptation of the Nijmegen Questionnaire following international guidelines for patient-reported outcome measures, and (2) psychometric evaluation of the Turkish version in a COPD population. The translation process includes forward translation, reconciliation, back-translation, developer review, cognitive debriefing with patients, and final proofreading. After completion of the linguistic adaptation, the NQ-TR will be administered to eligible participants at baseline and repeated after one week in clinically stable individuals to assess test-retest reliability. Construct validity will be evaluated using exploratory and confirmatory factor analyses. Convergent validity will be assessed by examining correlations between NQ-TR scores and established clinical measures, including the COPD Assessment Test (CAT), Modified Medical Research Council (mMRC) Dyspnea Scale, Hospital Anxiety and Depression Scale (HADS), and Dyspnea-12 (D-12). Internal consistency, test-retest reliability, and measurement stability will be analyzed.

Conditions

Interventions

TypeNameDescription
OTHERQuestionnairesAdministration of validated self-reported questionnaires (Nijmegen Questionnaire, CAT, mMRC, HADS, Dyspnea-12)

Timeline

Start date
2026-04-13
Primary completion
2027-01-01
Completion
2027-01-01
First posted
2026-01-15
Last updated
2026-04-15

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07344649. Inclusion in this directory is not an endorsement.