Not Yet RecruitingNot Applicable

Impact of Kolcaba Comfort Theory Training on Dyspnea, Function, and Comfort in COPD Patients

Turkey (Türkiye)80 participantsStarted 2024-09-10

Plain-language 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 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is based on something called Kolcaba Comfort Theory training — can you explain what that kind of nursing-based comfort training actually involves day-to-day, and whether it might be a good fit for where I am in managing my COPD right now?
2The trial's primary measure is something called the Dyspnoea-12 Scale, which seems to focus on how breathlessness affects both the physical and emotional sides of life — does my current level of breathlessness suggest I might benefit from this kind of comfort-focused approach, compared to other options we could try?
3The trial status is listed as 'not yet recruiting,' so it hasn't started enrolling patients yet — given where my COPD is right now, does it make more sense to wait and see if this trial opens, or should we focus on standard treatments in the meantime?
4Since this trial is listed as Phase NA, which often means it's testing a non-drug intervention like an educational or comfort-care program, what does that mean for what's already known about whether this type of training is safe and beneficial for COPD patients like me?
5If I were eventually to consider this trial, how would the training sessions fit around my existing treatment schedule and any physical limitations I have with breathing and daily activity?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dyspnoea-12 Scale

Timeframe: five monts

Trial details

NCT IDNCT06588361

SponsorAtaturk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-10

Contact for this trial

şeyda karasu, dr.

+0905455495825 seyda.kelle@erzurum.edu.tr

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