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Not yet recruiting Not applicable NCT07482033

The Impact of Training on Self-Efficacy, Symptom Level, and Activities of Daily Living

No applicable phase (e.g. observational)
Conditions: Activities of Daily Living Chronic Obstructive Pulmonary Disease (COPD)

Sponsor: Istanbul Saglik Bilimleri University

trial.available_in: БГ
Overview
This study is a randomized, controlled experimental trial with a pretest-posttest design, conducted to evaluate the effects of Pecha Kucha-based education on self-efficacy, symptom level, and activities of daily living in individuals diagnosed with chronic obstructive pulmonary disease (COPD) receiving noninvasive mechanical ventilation support. The study will include two groups, and intergroup differences will be evaluated: 1. Control group 2. Intervention group Study Hypotheses H1: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) increases patients' self-efficacy levels. H2: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) reduces patients' symptom levels. H3: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) improves patients' activities of daily living.
Description
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: 1. Duration of COPD 2. 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 natu
Who can participate
Inclusion Criteria * Age 18 years or older * Diagnosed with chronic obstructive pulmonary disease (COPD) at least one year prior * Currently receiving treatment with noninvasive mechanical ventilation (NIMV) support * Ability to communicate verbally and in writing in a clear and sustainable manner * No severe visual or hearing impairment that would prevent understanding of educational materials * Basic ability to use a smartphone * Active use of the WhatsApp application on a personal smartphone * Technical capability to view educational materials sent via phone (e.g., internet access, video playback) * No prior education on NIMV delivered using the Pecha Kucha presentation technique * Adequate cognitive function to allow independent participation (e.g., no history of dementia or confusion) * Availability to attend educational and assessment sessions as scheduled Exclusion Criteria * Failure to attend planned educational sessions or inability to complete the study protocol * Voluntary withdrawal from the study, declared verbally or in writing * Death during the study period * Development of a serious health condition preventing continuation in the education program (e.g., hospitalization, acute exacerbation, deterioration in mental status) * Loss of phone or internet access preventing receipt of educational materials * Significant communication problems that substantially interfere with participation in the educational process
Interventions
Intervention Group
OTHER
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Days
Healthy volunteers
No
Start date
01.05.2026
Completion date
31.12.2026
Registry ID
NCT07482033
Source
clinicaltrials.gov
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