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

NCT04301700 | Unknown

• 1 other identifier: 2408
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Mediation; Fatigue; Symptoms and Signs

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions

Other Outcomes (1)

• Dyspnea

  Baseline

Study Arms (3)

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.

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.

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.

Interventions

mindfullness and relaxation BEHAVIORAL

three arms: mindfullness and relaxation

mindfulness meditation; relaxation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altindag, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Negotiating; Fatigue; Signs and Symptoms

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: April 20, 2018
• Primary Completion: March 20, 2020
• Study Completion: April 20, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

TU (1)