COPDNCT04301700
Effects of Progressive Muscle Relaxation and Mindfulness Meditation in Patients With Chronic Obstructive Pulmonary Disease
A study testing mindfullness and relaxation in people with COPD and Mediation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- What is being tested?
- mindfullness and relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2018to 20 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD, Mediation, Fatigue, Symptoms and Signs
- Being tested
- mindfullness and relaxation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Negotiating, Fatigue, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfullness and relaxationBehavioural
three arms: mindfullness and relaxation
| Study group | Role | What they receive |
|---|---|---|
| relaxation | Experimental | 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. Receives: Behavioral: mindfullness and relaxation |
| mindfulness meditation | Experimental | 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. Receives: Behavioral: mindfullness and relaxation |
| Control | No intervention | Patients will continue to receive standard nursing care and no further intervention will be made during the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dyspnea
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.
Measured: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
Change in fatigue
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.
Measured: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
Change in care dependency
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.
Measured: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start20 Apr 2018
- Primary completion20 Mar 2020 (estimated)
- Study completion20 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Helvaci, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301700
- Sponsor's protocol ID
- 2408
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04301700
- Acronym / sponsor ID
- 2408
- Conditions
- COPD, Mediation, Fatigue, Symptoms and Signs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 20 Mar 2020 (estimated)
- Study completion
- 20 Apr 2020 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| relaxation | Experimental | Behavioral: mindfullness and relaxationThe 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. |
| mindfulness meditation | Experimental | Behavioral: mindfullness and relaxationThe 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. |
| Control | No intervention | –Patients will continue to receive standard nursing care and no further intervention will be made during the research. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfullness and relaxationthree arms: mindfullness and relaxation | Behavioural | mindfulness meditation, relaxation |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfullness and relaxation in people with COPD and Mediation, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dyspnea (time frame: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.