Turkish Validation of the Nijmegen Questionnaire in COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Turkish version of the Nijmegen Questionnaire (NQ-TR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older
- •Diagnosis of COPD confirmed according to GOLD criteria
- •Clinically stable disease (no acute exacerbation or hospitalization within the last 4 weeks)
- •Ability to read and understand Turkish
- •Willingness to participate and provide written informed consent
排除标准
- •Acute COPD exacerbation or respiratory infection within the previous 4 weeks
- •Presence of severe cardiac, neurological, or systemic disease affecting questionnaire responses
- •Coexisting pulmonary conditions such as bronchiectasis, lung cancer, prior pulmonary tuberculosis, pleural disease, or history of lung surgery
- •Moderate to severe cognitive impairment or communication difficulties
- •Severe visual or hearing impairment preventing questionnaire completion
- •Pregnancy
- •Refusal to participate or withdrawal during the study
研究组 & 干预措施
COPD
干预措施: Questionnaires (Other)
结局指标
主要结局
Turkish version of the Nijmegen Questionnaire (NQ-TR)
时间窗: Baseline and 1 week
The Nijmegen Questionnaire is a validated self-report instrument used to assess symptoms related to dysfunctional breathing and hyperventilation. It consists of 16 items evaluating the frequency of respiratory and non-respiratory symptoms, with higher total scores indicating greater symptom severity. In this study, the Turkish-validated version of the Nijmegen Questionnaire (NQ-TR) will be used to evaluate dysfunctional breathing symptoms in participants.
次要结局
- COPD Assessment Test (CAT)(Baseline)
- Modified Medical Research Council (mMRC) Dyspnea Scale(Baseline)
- Dyspnea-12 (D-12) Scale(Baseline)
- Hospital Anxiety and Depression Scale (HADS)(Baseline)
研究者
ESRA PEHLIVAN
Principal Investigator
Saglik Bilimleri Universitesi