Validation of the Turkish Version of the S3-NIV Questionnaire
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Turkish Version of the S3-NIV Questionnaire.
- Who it may be relevant to
- Registry conditions: Respiratory Insufficiency, Chronic Respiratory Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reliability and Validity of the Turkish Version of the Severe Respiratory Insufficiency Questionnaire for Non-Invasive Ventilation (S3-NIV)
Overview
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.
Detailed description
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.
Interventions
- Other Turkish Version of the S3-NIV Questionnaire
An 11-item self-administered questionnaire designed to evaluate the difficulties and compliance of patients using home non-invasive ventilation (NIV).
Primary outcome measures
- Internal Consistency and Construct Validity of the Turkish S3-NIV [Time frame: Baseline (Day 0)]
Secondary outcome measures (1)
- Test-Retest Reliability [Time frame: 14 to 15 days after baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital — Istanbul
Identifiers
NCT: NCT07610122 · 26/40