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Intensive Meditation and Migraines: Effects on Health and Well Being

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00663585
First received: April 21, 2008
Last updated: February 11, 2010
Last verified: October 2008

April 21, 2008
February 11, 2010
April 2008
October 2011   (final data collection date for primary outcome measure)
number of migraine days, number of headache days [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
# of migraine days, # of headache days [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00663585 on ClinicalTrials.gov Archive Site
  • severity of headaches [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
  • Heart Rate Variability [ Time Frame: 3,6,12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intensive Meditation and Migraines: Effects on Health and Well Being
Intensive Meditation and Migraines: Effects on Health and Well Being

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Daily Headache
Behavioral: Vipassana Meditation
12 day retreat where participants learn to meditate
  • Experimental: 1
    Structured Intervention Group
    Intervention: Behavioral: Vipassana Meditation
  • Active Comparator: 2.Comparison group
    Unstructured comparison group
    Intervention: Behavioral: Vipassana Meditation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Madhav Goyal, MD, MPH (410) 502-8814 madhav@jhmi.edu
United States
 
NCT00663585
NA_00016428, RR023266
Yes
Madhav Goyal, Assistant Professor, Johns Hopkins School of Medicine, Dept of Medicine
Johns Hopkins University
Not Provided
Study Director: Madhav Goyal, MD, MPH Johns Hopkins University
Johns Hopkins University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP