Effects of Progressive Muscle Relaxation and Mindfulness Meditation in Patients With Chronic Obstructive Pulmonary Disease
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04301700 |
Recruitment Status : Unknown
Verified March 2020 by Aylin Helvaci, Hacettepe University.
Recruitment status was: Active, not recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COPD Mediation Fatigue Symptoms and Signs | Behavioral: mindfullness and relaxation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel Assignment |
Masking: | Single (Participant) |
Masking Description: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
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 |
Actual Study Start Date : | April 20, 2018 |
Estimated Primary Completion Date : | March 20, 2020 |
Estimated Study Completion Date : | April 20, 2020 |
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.
|
Behavioral: mindfullness and relaxation
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.
|
Behavioral: mindfullness and relaxation
three arms: mindfullness and relaxation |
No Intervention: Control
Patients will continue to receive standard nursing care and no further intervention will be made during the research.
|
- 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.
- Dyspnea [ Time Frame: Baseline ]The Dyspnea-12 Scale
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301700
Turkey | |
Hacettepe University | |
Ankara, Altindag, Turkey, 06100 |
Responsible Party: | Aylin Helvaci, Research assistant, Hacettepe University |
ClinicalTrials.gov Identifier: | NCT04301700 |
Other Study ID Numbers: |
2408 |
First Posted: | March 10, 2020 Key Record Dates |
Last Update Posted: | March 10, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Fatigue Lung Diseases |
Respiratory Tract Diseases Chronic Disease Disease Attributes Pathologic Processes |