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| Name | Class |
|---|---|
| Eden Stiftung | UNKNOWN |
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Primary study objectives
Secondary study objectives
Evaluation of the medium-term effect of the intervention on headache frequency as well as the short- and medium-term effect on the secondary target parameters in comparison to the waiting group and MBSR. Further evaluation of the safety and acceptability of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iyengar Yoga Intervention | Experimental | 8-week yoga class; once weekly; 90 minutes Note: First administered face-to-face, due to Covid-restrictions changed to online classes |
|
| Mindfulness-based stress reduction | Active Comparator | 8-week MBSR class; once weekly; 90 minutes Note: First administered face-to-face, due to Covid-restrictions changed to online classes |
|
| Waitlist control | No Intervention | Waitlist control, ususal care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iyengar Yoga | Behavioral | Classical Iyengar Yoga intervention, especially designed for headache patients. Note: First administered face-to-face, due to Covid-restrictions changed to online classes |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Frequency | Headache Frequency self-reported by a headache diary | post-intervention (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Frequency | Headache Frequency self-reported by a headache diary | follow-up (20 weeks) |
| Duration of headache episodes | Duration of headache episodes self-reported by a headache diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustav Dobos, MD | University of Duisburg-Essen, Faculty of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evang. Kliniken Essen-Mitte | Essen | North Rhine-Westphalia | 45276 | Germany |
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| ID | Term |
|---|---|
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Mindfulness-based stress reduction | Behavioral | Standardazied Mindfulness-based stress reduction intervention Note: First administered face-to-face, due to Covid-restrictions changed to online classes |
|
| post-intervention (8 weeks) |
| Duration of headache episodes | Duration of headache episodes self-reported by a headache diary | follow-up (20 weeks) |
| Pain Intensity | Numeric rating scale | post-intervention (8 weeks) |
| Pain Intensity | Numeric rating scale (NRS) | follow-up (20 weeks) |
| Pain medication use | Pain medication use self-reported by a headache diary | post-intervention (8 weeks) |
| Pain medication use | Pain medication use self-reported by a headache diary | follow-up (20 weeks) |
| Headache related disability | Headche Impact Test 6 (HIT-6) | post-intervention (8 weeks) |
| Headache related disability | Headche Impact Test 6 (HIT-6) | follow-up (20 weeks) |
| Health-related quality of life | SF-36 questionaire | post-intervention (8 weeks) |
| Health-related quality of life | SF-36 questionaire | follow-up (20 weeks) |
| Anxiety | Depression and Anxiety scale (DAAS) | post-intervention (8 weeks) |
| Anxiety | Depression and Anxiety scale (DAAS) | follow-up (20 weeks) |
| Stress | Depression and Anxiety scale (DAAS) | post-intervention (8 weeks) |
| Stress | Depression and Anxiety scale (DAAS) | follow-up (20 weeks) |
| Pain catastrophizing | Pain catastrophizing scale (PCS) | post-intervention (8 weeks) |
| Pain catastrophizing | Pain catastrophizing scale (PCS) | follow-up (20 weeks) |
| Pain acceptance | Chronic pain acceptance questionaire (CPAQ) | post-intervention (8 weeks) |
| Pain acceptance | Chronic pain acceptance questionaire (CPAQ) | follow-up (20 weeks) |
| Mindfulness | Mindfulness Attention and Awerness scale (MAAS) | post-intervention (8 weeks) |
| Mindfulness | Mindfulness Attention and Awerness scale (MAAS) | follow-up (20 weeks) |
| Body Awareness | Body Awareness questionaire (BAQ) | post-intervention (8 weeks) |
| Body Awareness | Body Awareness questionaire (BAQ) | follow-up (20 weeks) |
| Safety | Adverse events | post-intervention (8 weeks) |
| Safety | Adverse events | follow-up (20 weeks) |
| D009422 | Nervous System Diseases |
| D004191 |
| Behavioral Disciplines and Activities |