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

NCT06588361 | Not Yet Recruiting DMC

• 1 other identifier: seydakarasu
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Main Heading (Descriptor) Terms

Keywords

COPD; Dyspnea; Functional Status; Comfort States; Kolcaba's Comfort Theory; Education

Outcome Measures

Primary Outcomes (1)

• 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.

  five monts

Secondary Outcomes (1)

• Clinical COPD Questionnaire

  five monts

Other Outcomes (1)

• General Comfort Scale Short Form GCS-SF

  five monts

Study Arms (1)

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.

Other: Training Based on Kolcoba Comfort Theory

Interventions

Training Based on Kolcoba Comfort Theory OTHER

Training Based on Kolcoba Comfort Theory

COPD patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead
• Scientific Research Projects Coordination Unit: collaborator

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

şeyda karasu, dr.

CONTACT

+0905455495825; seyda.kelle@erzurum.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: It is a randomized controlled experimental study

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion: May 10, 2025
• Study Completion: June 10, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TU (1)