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NCT Number: NCT06588361

Impact of Kolcaba Comfort Theory Training on Dyspnea, Function, and Comfort 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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, Turkey (Türkiye)

Location contact

şeyda karasu, Dr.

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training Based on Kolcoba Comfort Theory

Other

Training Based on Kolcoba Comfort Theory

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical COPD Questionnaire

    Time frame: five monts

    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

Other outcomes

  1. General Comfort Scale Short Form GCS-SF

    Time frame: five monts

    Its validity and reliability was performed by Sarıtaş et al. in 2018. It includes the sub-dimensions of comfort, relief (9 items), relaxation (9 items) and overcoming problems (10 items). In the evaluation of the scale consisting of positive and negative items, negative items are reverse coded and summed. The total score obtained is divided by the number of scale items and the mean value is found. The lowest possible value of 1 indicates a low comfort level and the highest value of 6 indicates a high comfort level. Reverse expressions: 2,3,7,8,8,9,10,11,12,13,14,15,16,18,20,21,23,24,25,27. The lowest possible value of 1 indicates low comfort and the highest value of 6 indicates high comfort.

Study contacts

Contact information is provided by the study sponsor or research team.

şeyda karasu, dr.

CONTACT

[email protected]

+0905455495825

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Collaborators

  • Scientific Research Projects Coordination Unit

Registry information

Official study title

Examination of the Effect of Training Based on Kolcoba Comfort Theory on Dyspnea, Functional Status and Comfort Status in COPD Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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