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

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
      • 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.
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.

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.

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

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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