Reliability and Validity of the Turkish Version of the Severe Respiratory Insufficiency Questionnaire for Non-Invasive Ventilation (S3-NIV)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the psychometric properties, including reliability and validity, of the Turkish version of the Severe Respiratory Insufficiency Questionnaire for Non-Invasive Ventilation (S3-NIV). The S3-NIV is a specific tool designed to assess difficulties and compliance in patients receiving home non-invasive ventilation. A total of 120 stable patients using home NIV for at least 3 months will be enrolled across multiple centers.
详细描述
Following the official linguistic validation process authorized by the Mapi Research Trust, this multi-center observational study will assess the psychometric validity of the Turkish S3-NIV questionnaire. Patients will complete the 11-item S3-NIV questionnaire alongside a sociodemographic and clinical data form. To evaluate test-retest reliability, a randomly selected subgroup of patients (n=40) will re-complete the questionnaire 14 to 15 days after the initial administration. Internal consistency, construct validity (via factor analysis), and criterion validity (correlations with clinical parameters such as daily NIV usage hours and blood gas values) 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with chronic respiratory failure requiring home non-invasive ventilation (NIV).
- •Using a home NIV device for at least 3 months.
- •Being in a clinically stable phase (no exacerbation or hospitalization in the last 1 month).
- •Able to understand and answer the questionnaire.
- •Provided written informed consent.
排除标准
- •Acute respiratory failure or clinical instability.
- •Severe cognitive impairment or psychiatric disorders preventing reliable communication.
- •Active malignancy or terminal illness with a short life expectancy.
- •Refusal to provide informed consent.
研究者
Dilek Unsal
Physiotherapist, PhD (c)
Istanbul Saglik Bilimleri University