Main Heading (Descriptor) TermsNCT06588361
Impact of Kolcaba Comfort Theory Training on Dyspnea, Function, and Comfort in COPD Patients
A study testing Training Based on Kolcoba Comfort Theory in people with Main Heading (Descriptor) Terms, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is the third most fatal chronic disease worldwide, following cardiovascular diseases and cancer. COPD is characterized by chronic respiratory symptoms due to abnormalities in the airways (bronchitis/bronchiolitis) or alveoli (emphysema), leading to persistent and often… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Main Heading (Descriptor) Terms
- What is being tested?
- Training Based on Kolcoba Comfort Theory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2024to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older.
- Have been diagnosed with COPD for at least 6 months.
- Be in GOLD stages 1, 2, or 3 of COPD.
- Be able to read and write in Turkish.
- Have access to a phone for communication.
Who cannot join
- Patients experiencing an acute exacerbation.
- Presence of non-COPD pulmonary problems or diagnosed cardiovascular diseases.
- Psychiatric disorders that disrupt thought processes, such as dementia or schizophrenia.
- Respiratory issues caused by diseases other than COPD.
- Problems with communication or speech.
- Use of a respiratory exercise device (PEP).
- Inability to tolerate PEP use.
- Desire to withdraw from the study at any point.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of the Effect of Training Based on Kolcoba Comfort Theory on Dyspnea, Functional Status and Comfort Status in COPD Patients
Chronic Obstructive Pulmonary Disease (COPD) is the third most fatal chronic disease worldwide, following cardiovascular diseases and cancer. COPD is characterized by chronic respiratory symptoms due to abnormalities in the airways (bronchitis/bronchiolitis) or alveoli (emphysema), leading to persistent and often progressive airway obstruction. Patients frequently experience a range of physical and psychosocial symptoms, including dyspnea, cough, sputum production, fatigue, anxiety, and depression. Dyspnea, in particular, can significantly reduce quality of life, impair daily activities, and affect patient comfort.
Functional status is a crucial metric for assessing disease progression and symptom severity in COPD and is directly related to the intensity of symptoms such as dyspnea. Effective management of symptoms and enhancement of comfort levels are critical in COPD treatment. Kolcaba's Comfort Theory provides a comprehensive approach to nursing care by addressing physical, psychospiritual, social, and environmental dimensions of patient needs. This theory can be an effective guide for improving comfort in COPD patients.
The objective of this study is to evaluate the effects of using Kolcaba's Comfort Theory as a guide in managing symptoms and enhancing the quality of care for COPD patients, focusing on dyspnea, functional status, and comfort. The research aims to provide innovative insights into the impact of Comfort Theory-based nursing care in sensitive patient populations like those with COPD and to contribute valuable information for developing effective treatment and management strategies for symptom control.
- Conditions
- Main Heading (Descriptor) Terms
- Being tested
- Training Based on Kolcoba Comfort Theory
- Keywords
- COPD, Dyspnea, Functional Status, Comfort States, Kolcaba's Comfort Theory, Education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training Based on Kolcoba Comfort TheoryOther
Training Based on Kolcoba Comfort Theory
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Experimental | Experimental group will receive training based on Kolcaba's Comfort Theory once a week for 5 weeks.No interventions will be provided to the control group. Receives: Other: Training Based on Kolcoba Comfort Theory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnoea-12 Scale
It includes four Likert-type options (0=none, 1=mild, 2=moderate, 3=severe). The first seven items of the scale question the physical difficulties caused by dyspnoea in patients by evaluating whether the breath goes to all lungs, whether the patient has shortness of breath, whether there is difficulty in breathing, and whether there is effort while breathing. The remaining five items of the scale focus on the effects of breathing on emotional states such as stress, irritability, depression, distress and restlessness. The maximum score that can be obtained from the physical dimension of the scale is 21 and the maximum score that can be obtained from the emotional dimension is 15. The minimum score that can be obtained from the scale is 0 and the maximum score is 36. An increase in the score obtained from the scale indicates an increase in the severity of dyspnoea in the patient. In the original study of the scale, Cronbach's alpha value was reported as 0.90.
Measured: five monts
Secondary outcomes (1)
Clinical COPD Questionnaire
It is a questionnaire that enables the evaluation of functional status and symptoms in daily clinical practice. It consists of 10 questions questioning the last week, scored by the patient between 0-6. It consists of three areas: symptoms, mental status and functional status. The total score is calculated and divided by the number of questions, with a high score indicating a low health status (severity of COPD). The Cronbach's alpha value of the Clinical COPD Questionnaire adapted to the Turkish language was 0.90
Measured: five monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Main Heading (Descriptor) TermsStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- It is a randomized controlled experimental study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Research Projects Coordination Unit
- Responsible party
- Principal investigator, Şeyda Karasu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588361
- Sponsor's protocol ID
- seydakarasu
- Status last verified
- Sep 2024
- First submitted
- 26 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Effect of Training Based on Kolcoba Comfort Theory on Dyspnea, Functional Status and Comfort Status in COPD Patients
- ClinicalTrials.gov ID
- NCT06588361
- Acronym / sponsor ID
- seydakarasu
- Conditions
- Main Heading (Descriptor) Terms
- Keywords
- COPD, Dyspnea, Functional Status, Comfort States, Kolcaba's Comfort Theory, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- Scientific Research Projects Coordination Unit
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Obstructive Pulmonary Disease (COPD) is the third most fatal chronic disease worldwide, following cardiovascular diseases and cancer. COPD is characterized by chronic respiratory symptoms due to abnormalities in the airways (bronchitis/bronchiolitis) or alveoli (emphysema), leading to persistent and often progressive airway obstruction. Patients frequently experience a range of physical and psychosocial symptoms, including dyspnea, cough, sputum production, fatigue, anxiety, and depression. Dyspnea, in particular, can significantly reduce quality of life, impair daily activities, and affect patient comfort.
Functional status is a crucial metric for assessing disease progression and symptom severity in COPD and is directly related to the intensity of symptoms such as dyspnea. Effective management of symptoms and enhancement of comfort levels are critical in COPD treatment. Kolcaba's Comfort Theory provides a comprehensive approach to nursing care by addressing physical, psychospiritual, social, and environmental dimensions of patient needs. This theory can be an effective guide for improving comfort in COPD patients.
The objective of this study is to evaluate the effects of using Kolcaba's Comfort Theory as a guide in managing symptoms and enhancing the quality of care for COPD patients, focusing on dyspnea, functional status, and comfort. The research aims to provide innovative insights into the impact of Comfort Theory-based nursing care in sensitive patient populations like those with COPD and to contribute valuable information for developing effective treatment and management strategies for symptom control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It is a randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| COPD patients | Experimental | Other: Training Based on Kolcoba Comfort TheoryExperimental group will receive training based on Kolcaba's Comfort Theory once a week for 5 weeks.No interventions will be provided to the control group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 18 years of age or older.
- Have been diagnosed with COPD for at least 6 months.
- Be in GOLD stages 1, 2, or 3 of COPD.
- Be able to read and write in Turkish.
- Have access to a phone for communication.
Key exclusion criteria (8 listed)
- Patients experiencing an acute exacerbation.
- Presence of non-COPD pulmonary problems or diagnosed cardiovascular diseases.
- Psychiatric disorders that disrupt thought processes, such as dementia or schizophrenia.
- Respiratory issues caused by diseases other than COPD.
- Problems with communication or speech.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training Based on Kolcoba Comfort TheoryTraining Based on Kolcoba Comfort Theory | Other | COPD patients |
Primary outcome
Dyspnoea-12 Scale
Time frame: five monts
It includes four Likert-type options (0=none, 1=mild, 2=moderate, 3=severe). The first seven items of the scale question the physical difficulties caused by dyspnoea in patients by evaluating whether the breath goes to all lungs, whether the patient has shortness of breath, whether there is difficulty in breathing, and whether there is effort while breathing. The remaining five items of the scale focus on the effects of breathing on emotional states such as stress, irritability, depression, distress and restlessness. The maximum score that can be obtained from the physical dimension of the scale is 21 and the maximum score that can be obtained from the emotional dimension is 15. The minimum score that can be obtained from the scale is 0 and the maximum score is 36. An increase in the score obtained from the scale indicates an increase in the severity of dyspnoea in the patient. In the original study of the scale, Cronbach's alpha value was reported as 0.90.
1 secondary outcome
Clinical COPD Questionnaire
Time frame: five monts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Based on Kolcoba Comfort Theory in people with Main Heading (Descriptor) Terms, run by Ataturk University at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact şeyda karasu, dr. (+0905455495825, seyda.kelle@erzurum.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnoea-12 Scale (time frame: five monts). 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 19 Sep 2024.