Effect of Progressive Relaxation Exercıses on Dyspnea and Comfort Level in Individuals With COPD
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedFirst Submitted
Initial submission to the registry
June 11, 2024
CompletedFirst Posted
Study publicly available on registry
June 14, 2024
CompletedJune 17, 2024
June 1, 2024
8 months
June 11, 2024
June 14, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
dyspnea level
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
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
Study Arms (2)
progressive relaxation exercises
EXPERIMENTALPatients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks.
control
NO INTERVENTIONPatients in the control group did not receive any intervention other than standard care practices.
Interventions
Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Izmir Bakırcay University
Izmir, 35665, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayşegül Çelik, PhD
Izmir Bakircay University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst. Prof., RN, MSc, PhD
Study Record Dates
First Submitted
June 11, 2024
First Posted
June 14, 2024
Study Start
January 1, 2023
Primary Completion
August 15, 2023
Study Completion
August 30, 2023
Last Updated
June 17, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share