Study Population and Sample
The study population will consist of patients who apply to the pulmonology outpatient clinic of Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital. The study will include two groups, and differences between the groups will be examined.
The sample size of the study was calculated as follows. The effect size of the difference obtained between the intervention and control groups at interim follow-up in terms of the total COPD self-efficacy score was calculated using Cohen's d coefficient. The mean score was 2.16 ± 0.47 in the intervention group and 1.67 ± 0.43 in the control group. The calculated Cohen's d value was 1.08, indicating a large effect size according to Cohen (1988).
Based on the analysis performed using the G*Power 3.1 software, considering a large effect size (1.08), a significance level of 5% (α = 0.05), and a statistical power of 95% (1-β = 0.95), it was determined that at least 23 participants per group, for a total of at least 46 participants, would be required to obtain statistically robust results. Taking potential attrition into account, it was planned to recruit 30 participants per group, for a total sample size of 60 participants.
Randomization Within the scope of the study, patients diagnosed with chronic obstructive pulmonary disease (COPD) who present to the pulmonology outpatient clinic and meet the sampling criteria will be randomly assigned to either the intervention or control group using a computer-based stratified randomization method. Stratified sampling will be used in this study, as it is preferred when subgroups (strata) exist in the population and may influence study outcomes. For the effectiveness of this method, it is important that there are no substantial differences between strata and that each stratum is internally homogeneous.
Based on the relevant literature, two key factors that may affect activities of daily living, self-efficacy, and symptom levels in individuals with COPD were identified:
- Duration of COPD
- Duration of noninvasive mechanical ventilation (NIMV) use
According to these two factors, the 46 participants to be included in the study will be divided into four strata (2 × 2), based on two levels for each factor. Random assignment within homogeneous strata will minimize potential structural imbalances between the intervention and control groups.
Randomization will be performed by a computer, assigning participants within each stratum randomly to either the intervention or control group. The randomization process and group allocation will be planned and conducted in accordance with the CONSORT 2017 (Consolidated Standards of Reporting Trials) guidelines to ensure transparency, reproducibility, and scientific validity.
Blinding To prevent selection bias, allocation to the intervention and control groups will be performed by an individual who is not involved in the research process, using a computer-based system. Due to the nature of the intervention, the researcher cannot be blinded. Data analysis will be conducted by a statistician who is independent of the study process, thereby minimizing detection and statistical bias.
Data Collection Procedures Patients diagnosed with chronic obstructive pulmonary disease (COPD) who are receiving noninvasive mechanical ventilation (NIMV) and receiving care at Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital will be informed about the study. The eligibility of patients who agree to participate will be assessed according to the study inclusion criteria. Written informed consent will be obtained from eligible patients prior to data collection, after which the printed data collection forms will be administered.
Pilot Study Before initiating the data collection phase, a pilot study will be conducted with individuals who meet the inclusion criteria to assess the suitability of the data collection instruments, the clarity and comprehensibility of the educational intervention, and to identify potential issues related to the implementation process of the study. Participants included in the pilot study will not be included in the main study sample.
Data Collection Instruments Data will be collected using the Patient Information Form, Vital Signs Monitoring Form, Noninvasive Mechanical Ventilation Use Monitoring Form, COPD Assessment Test (CAT), Modified Medical Research Council (mMRC) Scale, Borg Dyspnea Scale, COPD Self-Efficacy Scale, London Chest Activities of Daily Living Scale, and the Pecha Kucha Education Evaluation Form.
Patient Information Form This form was developed by the researcher and consists of two sections: Sociodemographic Characteristics and Disease-Related Characteristics.
The sociodemographic characteristics section includes questions regarding age, sex, height, weight, educational level, marital status, living arrangement, employment status, occupation, economic status, smoking status, and alcohol use.The disease-related characteristics section includes questions on duration of COPD diagnosis, GOLD stage, presence of chronic diseases other than COPD, regularly used medications, use of psychiatric medications, use of sleep medications, medications and devices used for COPD, number of hospital visits and hospitalizations due to COPD in the past year, attendance at routine health check-ups, receipt of COPD-related education, vaccination status, and current participation in a pulmonary rehabilitation program. The form consists of a total of 29 questions.
Vital Signs Monitoring Form This form includes the following vital signs: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation. These parameters will be assessed in both the intervention and control groups at baseline (pretest), at the interim assessment one month after baseline, and at the final assessment three months after baseline.Vital signs will be measured by the researcher at Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital. Vital signs reflect the physiological status of the body and provide information on homeostatic balance and the individual's overall clinical condition. All measurements will be performed using calibrated devices. Measurement procedures will be carried out in accordance with the relevant literature.
Noninvasive Mechanical Ventilation Use Monitoring Form This form was developed by the researcher based on the relevant literature. It collects information on the mode of noninvasive mechanical ventilation, fraction of inspired oxygen (FiO₂), inspiratory positive airway pressure, expiratory positive airway pressure, respiratory rate, expiratory trigger sensitivity, inspiratory-to-expiratory ratio, positive end-expiratory pressure (PEEP), time of initiation and termination of ventilator use, time of day when the ventilator is used, and total daily duration of use.
COPD Assessment Test (CAT) The COPD Assessment Test (CAT) was developed by Jones et al. and has demonstrated validity and reliability in multiple languages worldwide. In the original study, the Cronbach's alpha coefficient was reported as 0.88. The Turkish validity and reliability study was conducted by Yorgancıoğlu et al., with a Cronbach's alpha internal consistency coefficient of 0.91. The CAT is a measure of health status in COPD and provides information on symptom burden, dyspnea, respiratory function, and health-related quality of life. It has excellent measurement properties and is highly sensitive to changes in disease status. The test assesses the impact of COPD on daily life and health status by evaluating symptoms such as cough, sputum production, dyspnea, fatigue, and limitations related to leaving the home. The CAT consists of eight items, each scored on a five-point scale. Total scores range from 0 to 40, with higher scores indicating greater disease severity and poorer health status. Scores are interpreted as follows: 0-10 (low impact), 11-20 (moderate impact), 21-30 (high impact), and 31-40 (very high impact). The CAT is a reliable and valid assessment tool for clinical practice.
Modified Medical Research Council Scale (mMRC) The Modified Medical Research Council (mMRC) scale was originally developed by the Medical Research Council to assess the severity of dyspnea during physical activities in individuals with and without disease and was later modified for use in respiratory diseases. It is a five-item scale based on various physical activities that provoke dyspnea. The mMRC scale is used to grade the impact of dyspnea on daily activities. Patients are asked to indicate the level of activity that causes breathlessness. Dyspnea severity is graded from 0 to 4, where 0 indicates "no breathlessness," and higher grades indicate increasing severity of dyspnea.
Modified Borg Scale The Borg Scale was developed by Borg (1990) to measure perceived exertion during physical exercise. The Modified Borg Scale is closely associated with respiratory function tests and is easy to administer. It allows patients to describe the severity of dyspnea and is commonly used to assess both exertional and resting dyspnea. The scale is a unidirectional measure consisting of 10 categories. Scores range from 0 to 10, where 0 indicates no dyspnea and 10 indicates very severe dyspnea.
COPD Self-Efficacy Scale The COPD Self-Efficacy Scale was developed by Wigal et al. (1991), with a Cronbach's alpha coefficient of 0.95 reported in the original study. The Turkish validity and reliability study was conducted by Kara and Mirci (2002), yielding a Cronbach's alpha internal consistency coefficient of 0.94. This five-point Likert-type scale consists of 34 items and five subscales and assesses the level of confidence in managing or avoiding breathing difficulties during various activities in patients with COPD. The five subscales are negative affect, emotional arousal, physical exertion, environmental factors, and behavioral risk factors. The negative affect subscale assesses confidence in managing breathing difficulties in stressful situations. The emotional arousal subscale evaluates confidence in coping with dyspnea during emotional distress such as anger, fear, and anxiety. The physical exertion subscale assesses coping with situations that may provoke dyspnea, such as rapid stair climbing or cold weather conditions. The behavioral risk factors subscale evaluates behaviors such as nonadherence to diet or treatment and dyspnea-related behaviors. Each item is scored from 1 ("not at all confident") to 5 ("very confident"). The total score is calculated by summing item scores and dividing by the total number of items. Higher scores indicate greater confidence in managing or avoiding breathing difficulties.
London Chest Activities of Daily Living Scale The London Chest Activities of Daily Living (LCADL) Scale was developed by Garrod et al. (2000), with a Cronbach's alpha internal consistency coefficient of 0.98 reported in the original study. The Turkish validity and reliability study was conducted by Met (2009), with a Cronbach's alpha coefficient of 0.97. The LCADL is a simple questionnaire developed to assess dyspnea related to activities of daily living in patients with COPD. It consists of 15 items divided into four domains: personal care (4 items: drying, dressing the upper body, putting on shoes/socks, washing hair), household activities (6 items: making the bed, changing bed linens, washing windows/curtains, cleaning/dusting, washing dishes, vacuuming), physical activities (2 items: climbing stairs, bending), and leisure activities (3 items: walking indoors, going out socially, talking). Each item is scored from 0 to 5, yielding a maximum total score of 75. Higher scores indicate greater limitation in performing activities of daily living, whereas lower scores indicate higher activity levels.
Pecha Kucha Education Evaluation Form This form was developed by the researcher based on the literature and refined through expert opinion. It was designed to assess the views of individuals diagnosed with COPD in the study sample regarding the education program delivered using the Pecha Kucha presentation technique and WhatsApp. The form consists of three open-ended questions addressing participants' perceptions of the education provided, components of the educational video they found insufficient or unnecessary, and their opinions regarding the Pecha Kucha presentation technique.
