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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04739488
Other study ID # Yasemin Ceyhan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2017
Est. completion date December 25, 2019

Study information

Verified date February 2021
Source Kirsehir Ahi Evran Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The most common symptom of chronic obstructive pulmonary disease (COPD) is shortness of breath and causes a decrease in the patient's quality of life. The best way to relieve shortness of breath is inhaler therapy. However, it is known that patients frequently apply this treatment incorrectly. The aim of this study is to determine the effects of breathing exercises and inhaler training for COPD patients on the severity of dyspnea and life quality. For this, two patient groups with a total of 67 people were included in the study. While one group was trained on inhaler drug use, the other group was taught breathing exercises in addition to the inhaler drug use training. Patients were asked to continue the practices they learned regularly for 4 weeks. At the end of the study, it was observed that shortness of breath decreased and the quality of life increased in both patient groups.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date December 25, 2019
Est. primary completion date December 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The individuals over the age of 18, - Who had been diagnosed with COPD for at least three months, - Using inhalers at least twice a day, - Misusing their drug, - Had not previously taken breathing exercise training - Had not participated in a rehabilitation program Exclusion Criteria: - Mental disorders, - Communication disabilities, - Heart disease that could lead to dyspnea, - Unstable angina

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Inhaler training
This training was given to both intervention groups. How the patients used their inhaler medication was evaluated. The steps to use the correct inhaler medication were taught sequentially. It was applied with the patient. At the end of the training, brochures prepared by the researchers were given to the patients.
Behavioral:
Breathing exercises
This training was given only to the group that received breathing exercise and inhaler training. Pursed lips breathing exercises were taught to the patients. Patients were asked to continue their breathing exercise for 10 minutes before using their inhaler medication. Thus, it was evaluated whether breathing exercises performed before using inhaler drugs provided benefit on drug effectiveness.

Locations

Country Name City State
Turkey Kirsehir Ahi Evran University Faculty of Health Sciences Kirsehir Centrum

Sponsors (2)

Lead Sponsor Collaborator
Kirsehir Ahi Evran Universitesi Assistant Professor Pinar TEKINSOY KARTIN

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Information Form Consisted of 19 questions including sociodemographic and disease features of the patients It was administered to patients in both groups when they were first included in the study.
Primary Breathing Exercise and Inhaler Application Skill Chart Consisted of 18 items including the steps of breathing exercises and inhaler utilization to be applied to breathing exercises and inhaler group. It was administered to patients in breathing ezercises and inhaler training group when they were first enrolled in the study.
Primary Inhaler Application Skill Chart Consisted of 10 items including only the skill of applying inhaler to be applied to the both group.
Correct steps were evaluated as 1 point and wrong steps as 0 points. It was administered to patients when they were first enrolled in the study and when they came for control four weeks later.
It was administered to patients in inhaler training group when they were first enrolled in the study.
Primary COPD assessment test (CAT) The scale developed by Jones et al. (2009) is used to measure the health status of individuals with COPD. It was administered to patients in both groups when they were first enrolled in the study.
Primary St. George's respiratory questionnaire (SGRQ) It is a quality of life questionnaire specific to patients with COPD developed by Jones and Forde (2008). It was administered to patients in both groups when they were first enrolled in the study.
Primary Modified medical research council (mMRC) It was developed by the British Medical Research Council in order to provide information about the degree of dyspnea experienced by the patient based on the patient's activity and the patient's perception of the disease. As it is a one-dimensional scale Cronbach's a coefficient could not be calculated. It was administered to patients in both groups when they were first enrolled in the study.
Secondary COPD assessment test (CAT) The scale developed by Jones et al. (2009) is used to measure the health status of individuals with COPD. It was administered to patients in both groups when they came for control four weeks later.
Secondary Breathing Exercise and Inhaler Application Skill Chart Consisted of 18 items including the steps of breathing exercises and inhaler utilization to be applied to breathing exercises and inhaler group. It was administered to patients in breathing ezercises and inhaler training group when they came for control four weeks later.
Secondary Inhaler Application Skill Chart Consisted of 10 items including only the skill of applying inhaler to be applied to the both group.
Correct steps were evaluated as 1 point and wrong steps as 0 points. It was administered to patients when they were first enrolled in the study and when they came for control four weeks later.
It was administered to patients in inhaler training group when they came for control four weeks later.
Secondary St. George's respiratory questionnaire (SGRQ) It is a quality of life questionnaire specific to patients with COPD developed by Jones and Forde (2008). It was administered to patients in both groups when they came for control four weeks later.
Secondary Modified medical research council (mMRC) It was developed by the British Medical Research Council in order to provide information about the degree of dyspnea experienced by the patient based on the patient's activity and the patient's perception of the disease. As it is a one-dimensional scale Cronbach's a coefficient could not be calculated. It was administered to patients in both groups when they came for control four weeks later.
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