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Trial record 2 of 49 for:    relaxation | Copd

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 : Active, not recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Aylin Helvaci, Hacettepe University

Brief 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.

Condition or disease Intervention/treatment Phase
COPD Mediation Fatigue Symptoms and Signs Behavioral: mindfullness and relaxation Not Applicable

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.

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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

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. Dyspnea [ Time Frame: Baseline ]
    The Dyspnea-12 Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Turkey
Hacettepe University
Ankara, Altindag, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Fatigue
Lung Diseases
Respiratory Tract Diseases