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Activities of Daily LivingNCT07482033

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

A study testing Intervention Group in people with Activities of Daily Living and Chronic Obstructive Pulmonary Disease (COPD), run by Istanbul Saglik Bilimleri University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 days and older
What is being tested?
Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 May 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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

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:

Read more
  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.

Read the detailed 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 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.

Being tested
Intervention Group
Keywords
self-efficacy, symptom severity, activities of daily living, Chronic Obstructive Pulmonary Disease, Pecha Kucha
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention GroupOther

    Participants in the intervention group will receive education on mechanical ventilator support using the Pecha Kucha presentation technique. The educational content will include symptom control, energy conservation strategies for sleep and daily activities, the definition and benefits of noninvasive mechanical ventilation, potential complications, mask types, ventilator components, humidification in noninvasive mechanical ventilation, proper application of the ventilator, and cleaning and maintenance procedures. The presentation will consist of 20 slides and will last approximately 6-7 minutes. The training video will be sent weekly to the intervention group for a period of three months.

Study groups in NCT07482033
Study groupRoleWhat they receive
Control GroupNo interventionAt 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 GroupExperimentalIn 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.
Receives: Other: Intervention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self Efficacy

    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.

    Measured: 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.

  2. Symptom Level

    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.

    Measured: 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

  3. Daily Living Activities

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07482033
Sponsor's protocol ID
IstanbulSBU
Status last verified
Mar 2026
First submitted
6 Jan 2026
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie the results reported in publications derived from this study will be made available to qualified researchers. Shared data will include de-identified datasets and related data dictionaries.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group in people with Activities of Daily Living and Chronic Obstructive Pulmonary Disease (COPD), run by Istanbul Saglik Bilimleri University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nazli Kara (+905318884454, nazlikara2010@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self Efficacy (time frame: 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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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