Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency and Functionality: a Single Arm Study
Purpose
This research will explore the effect of the Transcendental Meditation® Technique on migraine intensity and frequency. It will be a single-arm pilot study involving 30 female participants recruited from migraine treatment facilities and support groups in the US.
Conditions
- Migraine
- Migraine with or Without Aura
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Female by birth - Diagnosis of migraine with or without aura, based on ICHD3 criteria - 6-14 migraine days/month. - ≥ one year history of migraines starting before the age of 50. - ≥ 18 years old or ≤ 55 Years old - Willing to attend follow-up sessions. - Willing to practice TM twice a day for 20 minutes. - Agreeable to participate and to be randomized to either group. - Fluent in English. Willing to continue same medication without any additional medicine In good general health with no other diseases expected to interfere with the study.
Exclusion Criteria
- > 55 years old or < 18 Years old - Already practicing Transcendental Meditation. - Pre-diagnosed major systemic illness or unstable medical/psychiatric condition (eg, suicide risk) requiring immediate treatment or that could compromise protocol adherence - Medication overuse headache (MOH) - Current/planned pregnancy or breastfeeding - New prophylactic migraine medicine started within 4 weeks of the screening visit - Unwilling to maintain stable migraine medication dosages - Failure to complete baseline headache logs.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- It is a pilot study investigating the impact of Transcendental Meditation on migraine as a basis for a larger randomized control study.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Exploring the Effect of the Transcendental Meditation® Technique on Migraine |
|
Recruiting Locations
Washington, District of Columbia 20036
More Details
- Status
- Recruiting
- Sponsor
- Maharishi International University
Detailed Description
The objective of this study is to assess the safety, feasibility, and effects of the practice of the Transcendental Meditation technique in adults with migraines. This study will involve 30 female participants recruited from migraine treatment facilities and migraine support groups in the US. The study will span three months, with all participants practicing Transcendental Meditation (TM) while continuing their usual lifestyle and medication regimen. Pre-data will be collected through symptom analysis, headache patterns, and evaluation questionnaires. All potential subjects will keep a daily migraine diary for 30 days before inclusion in the study, both to assess migraine status and to adhere to study protocols during the study. All the subjects will receive TM instruction, followed by bi-weekly group meetings and one-on-one sessions for 3 months to monitor progress and ensure correct practice.