The Effect of Pecha Kucha Training on Noninvasive Mechanical Ventilation Support for Individuals With Chronic Obstructive Pulmonary Disease on Self-Efficacy, Symptom Level, and Daily Living Activities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Self Efficacy
研究概览
简要总结
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:
- Control group
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Group
At baseline, pre-test data will be collected using the study data collection instruments. Patients will be asked to record their weekly duration of noninvasive mechanical ventilator use using the Noninvasive Mechanical Ventilator Use Monitoring Form throughout a three-month follow-up period. This group will receive the standard education and follow-up program routinely provided in the hospital, which includes physician-led training on prescribed ventilator usage duration and proper application of the device, along with monthly follow-up visits. No additional education based on the Pecha Kucha technique will be provided. Data collection instruments will be re-administered in the control group at the interim assessment conducted one month after baseline and at the final assessment conducted three months after baseline.
Pecha Kucha Education Group
In the intervention group, baseline (pre-test) data will be collected prior to the educational intervention. Participants will be asked to complete the Noninvasive Mechanical Ventilator Use Monitoring Form according to their ventilator use. Immediately after baseline data collection, education will be provided using the Pecha Kucha presentation technique. The educational content will include symptom control, energy conservation strategies for sleep and daily activities, definition and benefits of noninvasive mechanical ventilation, potential complications, mask types, ventilator components, humidification, proper application, and cleaning and maintenance of the device. After the Pecha Kucha-based education, the training video will be sent weekly to participants' mobile phones for three months. Data collection instruments will be re-administered at one month (interim assessment) and three months (final assessment) after baseline.
干预措施: Intervention Group (Other)
结局指标
主要结局
Self Efficacy
时间窗: Participants in the intervention group will receive baseline assessment, followed by Pecha Kucha-based training, with follow-up assessments at 1 and 3 months. The control group will be assessed at the same time points without education.
The COPD Self-Efficacy Scale is a 5-point Likert-type instrument consisting of 34 items and five subscales that assess patients' confidence in managing or avoiding dyspnea during specific activities. The five subscales are negative affect, emotional arousal, physical exertion, weather/environmental factors, and behavioral risk factors. The negative affect subscale measures confidence in managing dyspnea in stressful situations. The emotional arousal subscale assesses confidence in coping with dyspnea during emotional distress such as anger, fear, and life-related stress. The physical exertion subscale evaluates confidence in managing dyspnea during situations that may provoke breathlessness, such as rapid stair climbing or cold weather exposure. The behavioral risk factors subscale measures behaviors related to non-adherence to diet and treatment and dyspnea-related behaviors. Higher scores indicate greater confidence in managing or avoiding dyspnea. Total scores range from 34 to 170.
Symptom Level
时间窗: Baseline, 1 month, and 3 months. Participants in the Pecha Kucha education group will receive Pecha Kucha-based training after the baseline assessment and will be evaluated at 1 and 3 month follow-ups. The control group will be evaluated at the same time
The COPD Assessment Test (CAT) is an instrument used to assess the impact of COPD symptoms, including dyspnea, cough, sputum production, fatigue, and activity limitations, on daily life and overall health status. The CAT consists of 8 items and is simple and quick to administer. Each item is scored on a 5-point scale, with total scores ranging from 0 to 40. Higher scores indicate a greater impact of COPD symptoms and increased severity of dyspnea. Scores are categorized as low (0-10), moderate (11-20), high (21-30), and very high impact (31-40). The CAT is a reliable and valid tool widely used in clinical practice.
Daily Living Activities
时间窗: Participants in the intervention group will receive baseline assessment, followed by Pecha Kucha-based training, with follow-up assessments at 1 and 3 months. The control group will be assessed at the same time points without education.
The London Chest Activity of Daily Living Scale is a simple questionnaire developed to assess dyspnea related to daily living activities in patients with COPD. It consists of 15 items across four domains: personal care (4 items: drying, dressing the upper body, putting on shoes/socks, washing hair), domestic activities (6 items: making the bed, changing sheets, washing windows/curtains, cleaning/dusting, washing dishes, vacuuming), physical activity (2 items: climbing stairs, bending), and leisure activities (3 items: walking indoors, going out socially, talking). The maximum possible score is 75. Higher scores indicate greater limitation in performing daily activities, whereas lower scores reflect higher activity levels.
次要结局
未报告次要终点
研究者
Nazli Kara
PhD Student
Istanbul Saglik Bilimleri University