- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01577329
Mindfulness Mediation Intervention in Chronic Obstructive Pulmonary Disease (COPD)
April 21, 2017 updated by: Roxane Raffin Chan, University of Michigan
Mindfulness Mediation Intervention in COPD
The purpose of this study is to assess the feasibility and potential impact of an eight week program of meditation on expiratory time, anxiety and dyspnea in people with COPD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chronic Obstructive Pulmonary Disease is a progressive multi-dimensional disease with a complex network of somatic and affective components.
Anxiety is a common experience for persons with COPD both as a reaction to dyspnea (48) and as a separate co-morbid condition (10, 26).
The presence of anxiety magnifies COPD symptoms and further impairs physical functioning (53).
Both anxiety and COPD alter breathing patterns similarly causing irregular rapid shallow breathing at rest, which is inefficient and cannot adequately respond to increases in ventilatory demands from physical or emotional activity (121).
Both COPD and anxiety are also associated with changes in neurological functioning.
Whereas anxiety tends to be associated with increased amygdala activity (54), COPD is associated with a decrease in frontal cortex functioning (25, 28, 122).
Persons with COPD who experience anxiety are less able to correctly process the level of physical and emotional demand for any given situation and their ability to meet that demand (46, 123).
Pulmonary rehabilitation addresses both the physical and emotional symptoms of COPD, however gains in function are quickly lost over time (4).
Evidence suggests that mindfulness based meditation can alter neural pathways to facilitate processing of emotions and increase quality of life for persons with COPD.
The overall objective of this study is to assess the ability of persons with COPD to participate in a mindfulness meditation intervention and to examine the impact of mindfulness meditation on their anxiety levels and global sense of coherence.
A modified version of Antonovsky's sense of coherence model will be used as the framework for this study.
We will address the specific aims: 1) to determine the effects of mindfulness meditation on breathing patterns; 2) To determine the effects of mindfulness meditation on anxiety levels; 3) To determine self-reported adherence rates following an eight-week small group instructional course on mindfulness meditation, and 4) To determine the effects of mindfulness meditation on global sense of coherence levels in persons with COPD.
The National Center for Complementary and Alternative Medicine identifies meditation as a form of CAM that focuses on the interaction among the brain, body, mind and behavior that is already practiced by 8% of persons who participate in CAM therapy.
Meditation is rated a special priority research area by NCCAM.
Study Type
Interventional
Enrollment (Actual)
41
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
-
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Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
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
40 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Any stage of Chronic Obstructive Pulmonary Disease
- Able to read and write English
Exclusion Criteria:
- Severe mental disability
- Inability to attend
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: mindfulness meditation class
Group class on mindfulness meditation.
One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills.
Homework is assigned.
|
Group class on mindfulness meditation.
One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills.
Homework is assigned.
|
|
NO_INTERVENTION: wait list
Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Respiratory Rate
Time Frame: baseline and at week eight
|
Breathing patterns will be measured at baseline using inductive plethysmography at baseline and at week eight.
During that eight week time period the treatment group will have been exposed to a once a week mindfulness meditation class and the control group will have been exposed to health care as usual.
|
baseline and at week eight
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roxane R Chan, RN, PhD (c), University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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
October 1, 2011
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
July 1, 2015
Study Registration Dates
First Submitted
April 11, 2012
First Submitted That Met QC Criteria
April 12, 2012
First Posted (ESTIMATE)
April 13, 2012
Study Record Updates
Last Update Posted (ACTUAL)
August 2, 2017
Last Update Submitted That Met QC Criteria
April 21, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- um-nursing-meditation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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