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

Tracking Information

• First Submitted Date: March 6, 2020
• First Posted Date: March 10, 2020
• Last Update Posted Date: March 10, 2020
• Actual Study Start Date: April 20, 2018
• Estimated Primary Completion Date: March 20, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 9, 2020)

• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: March 9, 2020)

Dyspnea [ Time Frame: Baseline ]

The Dyspnea-12 Scale

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Effects of Progressive Muscle Relaxation and Mindfulness Meditation in Patients With Chronic Obstructive Pulmonary Disease
• 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
• 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.
• 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
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Parallel Assignment

Masking: Single (Participant)
Masking Description:

Single (Outcomes Assessor)

Primary Purpose: Supportive Care

Condition

• COPD
• Mediation
• Fatigue
• Symptoms and Signs

Intervention

Behavioral: mindfullness and relaxation

three arms: mindfullness and relaxation

Study Arms

• 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.
  Intervention: Behavioral: 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.
  Intervention: Behavioral: mindfullness and relaxation
• No Intervention: Control
  Patients will continue to receive standard nursing care and no further intervention will be made during the research.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: March 9, 2020): 65
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: April 20, 2020
• Estimated Primary Completion Date: March 20, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT04301700
• Other Study ID Numbers: 2408
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Aylin Helvaci, Hacettepe University
• Original Responsible Party: Same as current
• Current Study Sponsor: Hacettepe University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hacettepe University
• Verification Date: March 2020