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Intensive Meditation and Migraines: Effects on Health and Well Being

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00663585
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Madhav Goyal, Johns Hopkins University

Study Description
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Brief Summary:
Participants completing training in intensive meditation and continuing frequent practice for one year would experience reduced frequency, duration and severity of headaches along with improved awareness of the triggers of their symptoms, improved quality of life and mental health, improved heart rate variability, and reduced inflammation.

Condition or disease Intervention/treatment Phase
Chronic Daily Headache Behavioral: Vipassana Meditation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Meditation and Migraines: Effects on Health and Well Being
Study Start Date : April 2008
Actual Primary Completion Date : February 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Structured Intervention Group
 Behavioral: Vipassana Meditation
12 day retreat where participants learn to meditate
Active Comparator: 2.Comparison group
Unstructured comparison group
 Behavioral: Vipassana Meditation
12 day retreat where participants learn to meditate


Outcome Measures
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Primary Outcome Measures :
  1. number of migraine days, number of headache days [ Time Frame: 3,6,12 months ]

Secondary Outcome Measures :
  1. severity of headaches [ Time Frame: 3,6,12 months ]
  2. quality of life [ Time Frame: 3,6,12 months ]
  3. Heart Rate Variability [ Time Frame: 3,6,12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic Daily Headache, defined as a headache at least 15 days of the month, of which at least 8 are migraines.

Exclusion Criteria:1.

  • Severe depression, anxiety, panic attacks, psychosis or dementia that may interfere with ability to participate in a 10 day course
  • Active alcoholism on screening or use of illicit drugs within the last 3 months
  • Already completed a 10 day course
  • Actively involved in another form of meditation over the past 6 months
  • Women who are pregnant, planning pregnancy during trial period, or lactating.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663585


Locations
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United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Study Director: Madhav Goyal, MD, MPH Johns Hopkins University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Madhav Goyal, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00663585    
Other Study ID Numbers: NA_00016428
RR023266
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Keywords provided by Madhav Goyal, Johns Hopkins University:
Migraine
Headache
Vipassana
Meditation
Intensive
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders
Headache
Headache Disorders, Primary
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations