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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 participants recruited from migraine treatment facilities and support groups in the US.
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exploring the Effect of the Transcendental Meditation® Technique on Migraine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation | Behavioral | 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 male and 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 use a migraine App for 30 days prior to inclusion in the study, both as a means of assessing migraine status and of ability to adhere to study protocols during the study. In addition, all subjects will take the PHQ-9 to screen for levels of depression that might impair participation in the study. All the subjects will receive TM instruction, followed by bi-weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and functionality | Frequency and functionality will be measured by the data recorded in the migraine App. | 6 Months |
| The Migraine Disability Assessment (MIDAS) to measure frequency and functionality. | 6 Months | |
| Migraine Specific Quality of Life Questionnaire (MSQ), version 2.1 to measure impact on Quality of Life | 6 Months | |
| Questionnaire (MSQ), version 2.1 to measure impact on functionality. | 6 months |
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Inclusion criteria:
Willing to continue the same medication without any additional medicine
In good general health, with no other diseases expected to interfere with the study.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Fred T Travis, PhD | Maharishi International University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown Headache Center and DC area | Washington D.C. | District of Columbia | 20036 | United States |
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| Label | URL |
|---|---|
| Migraines and Meditation We are conducting research to see the effect of Transcendental Meditation (TM) on the intensity and frequency of migraines. | View source |
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This is a pilot study, and data will be used to design a larger RCT study.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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It is a pilot study investigating the impact of Transcendental Meditation on migraine as a basis for a larger randomized control study.
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|
| D009422 | Nervous System Diseases |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |