History of Changes for Study: NCT04301700

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

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Version	A	B	Submitted Date	Changes
1			March 9, 2020	None (earliest Version on record)

Study Identification


Unique Protocol ID:	2408
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
Secondary IDs:

Study Status


Record Verification:	March 2020
Overall Status:	Unknown status [Previously: Active, not recruiting]
Study Start:	April 20, 2018
Primary Completion:	March 20, 2020 [Anticipated]
Study Completion:	April 20, 2020 [Anticipated]

First Submitted:	March 6, 2020
First Submitted that Met QC Criteria:	March 9, 2020
First Posted:	March 10, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	March 9, 2020
Last Update Posted:	March 10, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	Hacettepe University
Responsible Party:	Principal Investigator Investigator: Aylin Helvaci Official Title: Research assistant Affiliation: Hacettepe University
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

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.

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.

Conditions


Conditions:	COPD Mediation Fatigue Symptoms and Signs
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Supportive Care
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
	Parallel Assignment
Number of Arms:	3
Masking:	Single (Participant)
Allocation:	Randomized
Enrollment:	65 [Actual]

Arms and Interventions

Arms	Assigned Interventions
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


Minimum Age:	40 Years
Maximum Age:
Sex:	All
Gender Based:
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/Locations


Locations:	Turkey, Altindag
	Hacettepe University Ankara, Altindag, Turkey, 06100

IPDSharing


Plan to Share IPD:	Undecided

References


Citations:
Links:
Available IPD/Information: