Intensive Meditation and Migraines: Effects on Health and Well Being

Chronic Daily Headache Clinical Trial

Official title:

Intensive Meditation and Migraines: Effects on Health and Well Being

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663585
• Other study ID #: NA_00016428
• Secondary ID: RR023266
• Status: Completed
• Phase: N/A
• First received: April 21, 2008
• Last updated: July 28, 2016
• Start date: April 2008
• Est. completion date: June 2014

Study information

• Verified date: July 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Daily Headache
• Headache
• Headache Disorders
• Migraine Disorders

Intervention

Behavioral:
• Vipassana Meditation
12 day retreat where participants learn to meditate

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of migraine days, number of headache days		3,6,12 months	No
Secondary	severity of headaches		3,6,12 months	No
Secondary	quality of life		3,6,12 months	No
Secondary	Heart Rate Variability		3,6,12 months	No