- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06459882
Effect of Progressive Relaxation Exercıses on Dyspnea and Comfort Level in Individuals With COPD
June 14, 2024 updated by: Aysegul Celik, Izmir Bakircay University
Effect of Progressive Relaxation Exercises on Dyspnea and Comfort Level in Individuals With Chronıc Obstructive Lung Disease: A Randomized Controlled Study
The study is a randomised controlled experimental study conducted to examine the effect of progressive relaxation exercises on dyspnea and comfort level in individuals with chronic obstructive pulmonary disease.
The study was conducted between January and August 2023 in the Internal Medicine Clinic of Izmir Urla State Hospital.
Stratified and block randomisation method was used in the study and 42 patients, 21 intervention group and 21 control group, were completed.
Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks.
Patients in the control group did not receive any intervention other than standard care practices.
The data of the study were collected by face-to-face interview method using the Descriptive Information Form, Medical Research Council Dyspnea Scale, General Comfort Scale-Short Form and Patient Follow-up Form.
Descriptive statistics, Shapiro Wilk test, Levene's test, Mauchly's W test, independent sample T test, Mann Whitney U test, dependent sample t test, Wilcoxon Signed Ranks test, Friedman test, Benferoni test and Fisher's Exact test were used to analyse the data obtained from the study.
It was determined that the mean dyspnea level scores of the patients in the intervention group at week 6 were lower than the control group and this difference between the groups was statistically significant (p<0.05).
It was determined that the decrease in the mean comfort level scores of the patients in the intervention group according to the follow-up periods was statistically significant (p<0.05).
According to the results of the study, progressive relaxation exercises can be recommended as an effective nursing intervention to provide dyspnea management in patients with COPD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Izmir, Turkey, 35665
- Izmir Bakırçay University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 years of age and over
- Inpatient treatment in the Internal Medicine Clinic of Izmir Urla State Hospital
- Standardised Mini Mental Test score ≥24
- Dyspnea severity ≥2 according to the MMRC dyspnoea scale
- Diagnosed with Stage II and Stage III COPD according to GOLD criteria
- Functional competence to participate in progressive relaxation exercises
- Able to access and use a smartphone
- COPD patients who agreed to participate in the study.
Exclusion Criteria:
- Have any speech and hearing problems
- Lung disease other than COPD, physical dependence and psychiatric illness diagnosed with
- COPD patients in the acute exacerbation period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: progressive relaxation exercises
Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks.
|
Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks
|
|
No Intervention: control
Patients in the control group did not receive any intervention other than standard care practices.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
dyspnea level
Time Frame: baseline, week 3, and week 6
|
Medical Research Council Scale: MMRC is an easily applicable 5-item scale that shows similar results with lung function tests and arterial blood gas measurement and is recommended for use in determining the dyspnea levels of COPD patients in GOLD guidelines.
The dyspnea level is graded between 0-4.
A score of 0 indicates the absence of dyspnea, and an increase in the rating indicates an increase in the severity of dyspnea.
|
baseline, week 3, and week 6
|
|
comfort level
Time Frame: baseline, week 3, and week 6
|
The scale consists of 28 items and three sub-dimensions: relief (9 items), relaxation (9 items) and overcoming problems (10 items).
The lowest value of 1 indicates a low comfort level and the highest value of 6 indicates a high comfort level.
In this study, the Cronbach alpha reliability coefficient of the scale was 0.74 for the intervention group and 0.82 for the control group.
|
baseline, week 3, and week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayşegül Çelik, PhD, Izmir Bakircay University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
August 15, 2023
Study Completion (Actual)
August 30, 2023
Study Registration Dates
First Submitted
June 11, 2024
First Submitted That Met QC Criteria
June 11, 2024
First Posted (Actual)
June 14, 2024
Study Record Updates
Last Update Posted (Actual)
June 17, 2024
Last Update Submitted That Met QC Criteria
June 14, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BakircaU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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