- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04301700
Effects of Progressive Muscle Relaxation and Mindfulness Meditation in Patients With Chronic Obstructive Pulmonary Disease
March 9, 2020 updated by: Aylin Helvaci, Hacettepe University
Effects of Progressive Muscle Relaxation and Mindfulness Meditation on Dyspnea, Fatigue and Care Dependency in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study
Patients with COPD will be entered.
Participants will be randomized to one of three study arms: Arm 1: meditation; Arm 2: relaxation; Arm 3: Control.
Hypothesis: Progressive muscle relaxation and mindfulness meditation will decrease severity of dyspnea, fatigue and care dependency.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Previous reports have revealed that progressive muscle relaxation and meditation are decreasing symptoms burden in chronic disease.
On the other hand, no study has been conducted to determine the effects of progressive relaxation exercise and mindfulness meditation on dyspnea, fatigue and care dependency in patients with COPD.
The present study investigates the effects of progressive muscle relaxation and mindfulness meditation in a single-site, 3-arm, assessor-blinded randomized, controlled study of 65 COPD patients.
Arm 1: meditation; Arm 2: relaxation; Arm 3: Control.The investigators hypothesize that Progressive muscle relaxation and mindfulness meditation will decrease the severity of dyspnea, fatigue and care dependency.
Study Type
Interventional
Enrollment (Actual)
65
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
-
-
Altindag
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Ankara, Altindag, Turkey, 06100
- Hacettepe 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
38 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- older than 40 years
- diagnosed with stage III-IV COPD
- had at least primary school degree
- had no cognitive dysfunction, or communication problems
- were residing in Ankara.
Exclusion Criteria:
- history of cognitive dysfunction, or communication problems
- illiteracy
- applying any complementary and integrative approach during the study
- participating in a pulmonary rehabilitation program during the study.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: relaxation
The progressive muscle relaxation intervention, designed by Jacobson (1987), will be consist of sessions involving straining and relaxing all muscle groups from head to foot with deep breathing and last for 20 min.
The patients will be asked to tense a very muscle group for 5 s and relax after counting up to 10 s while breathing out.
In this way, facial, head, neck, shoulders, arms, chest, abdomen, legs, hips, feet and fingers muscles are stretched and relaxed on purpose for relaxing in patients with COPD.
|
three arms: mindfullness and relaxation
|
Experimental: mindfulness meditation
The research team closely will be following the mindfulness meditation intervention, developed by Kabat-Zinn, Lipworth, and Burney (1985), which is a part of the mindfulness-based stress reduction program.
Mindfulness meditation is including interventions such as yoga, body scan, walking meditation, and sitting meditations.
In the present study, the researchers will prefer sitting meditation.
In this context, the second co-author will want patients to sit up in the chair in an upright and comfortable position.
The patients will focus on deep breathing and felled the breath flowing throughout their body during the interventions that will last for 20 min in each session.
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three arms: mindfullness and relaxation
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No Intervention: Control
Patients will continue to receive standard nursing care and no further intervention will be made during the research.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dyspnea
Time Frame: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
|
Dyspnea will be measured by The Dyspnea-12 Scale.
The range of total score was from 0 to 36, with higher scores demonstrating higher dyspnea level.
|
Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
|
Change in fatigue
Time Frame: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
|
Quality of live will be measured by Asthma Fatigue Scale (CAFS).
The CAFS scores is standardized to 0-100 in line with the following formula, (100 × (total score-minimum value to be obtained)/range), with higher scores indicating greater fatigue.
|
Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
|
Change in care dependency
Time Frame: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
|
Quality of live will be measured by Care Dependency Scale (CDS).
The sum of the scores changes from 17 to 85, with higher scores demonstrating lower dependence.
|
Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea
Time Frame: Baseline
|
The Dyspnea-12 Scale
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 20, 2018
Primary Completion (Anticipated)
March 20, 2020
Study Completion (Anticipated)
April 20, 2020
Study Registration Dates
First Submitted
March 6, 2020
First Submitted That Met QC Criteria
March 9, 2020
First Posted (Actual)
March 10, 2020
Study Record Updates
Last Update Posted (Actual)
March 10, 2020
Last Update Submitted That Met QC Criteria
March 9, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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