Effects of Progressive Muscle Relaxation and Mindfulness Meditation in Patients With Chronic Obstructive Pulmonary Disease

• ClinicalTrials.gov Identifier: NCT04301700
• Recruitment Status: Unknown
• First Posted: March 10, 2020
• Last Update Posted: March 10, 2020
• Sponsor: Hacettepe University
• Information provided by (Responsible Party): Aylin Helvaci, Hacettepe University

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Turkey

Hacettepe University

Ankara, Altindag, Turkey, 06100

Sponsors and Collaborators

Hacettepe University

More Information

• Responsible Party: Aylin Helvaci, Research assistant, Hacettepe University
• ClinicalTrials.gov Identifier: NCT04301700
• Other Study ID Numbers: 2408
• First Posted: March 10, 2020
• 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

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Fatigue; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes