To evaluate the effect of Introvision, a mental and emotional self-regulation-technique developed by Angelika C. Wager, as migraine preventative compared to a waiting list group.
Randomized, single-center, waiting-list control group study: Introvision as preventative in Migraine Randomized, single center, waiting-list group control study to evaluate the effect of Introvison, a mental and emotional self regulation method to reduce headache days in patients with migraine, migraine and tension type headache and chronic migraine. The number of headache days 3 months after completion of the last session of Introvision will be compared with the number of headache days of the waiting list group in the month before the course to learn Introvision.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
72
Participants learn Introvision
Hospital of the Ludwig-Maximilians-University
Munich, Bavaria, Germany
Number of Headache Days Per Month
The number of headache days per month 3 months after completion of the last session of Introvision will be compared with the number of headache days of the waiting list group in the month before the course to learn Introvision.
Time frame: approximately 4 months, as the course to learn Introvision and the three individual sessions will take nearly 2 months to be completed, and headaches per month will be assessed in the month 3 months after the last session of Introvision.
Headache Intensity
Headache intensity rated by the patients themselves with a scale in the headache diary: weak (=1) , moderate (=2), severe (=3) headache. Scores may range from 1 to 3. Average headache intensity of the attacks per months will be compared three months after the last session of Introvision compared to the values before Introvison.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Acute Medication Per Month
The number of days with acute medication against migraine attacks/headache per month 3 months after completion of the last session of Introvision will be compared with the number of days with acute medication per month before Introvision.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Number of Headache Days Per Month in Pooled Groups Analysis Before and 3 Months After Introvision as Parameter for the Efficacy of Introvision
number of headache days per months in pooled groups analysis before and 3 months after Introvision, measured with the number of headache days per months as in the primary outcome measure, but both groups together compared before Introvision and three months after the last session
Time frame: approximately 5-6 months
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Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF)
The headache specific self-efficacy scale (Headache Management Self-efficacy Scale-German-short form: HMSE-G-SF) consists of 6 items with a 7-point response scale which ranges from 1 (strongly disagree) to 7 (strongly agree).The 6 items measure self-efficacy beliefs, for instance: "There are things I can do to alleviate the headache". The scores for each of the six items are combined to compute the total score, that may range from 6 to 42 points. A higher score indicates a stronger self-efficacy in headache management. It is measured before Introvision and three month after the last session of Introvision.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Headache-Impact Test 6, HIT-6
Impact of headache (Headache-Impact Test 6, HIT-6), compared three months after the last session of Introvision to before introvision. The total score may range from 6 to 78 points, a higher score indicates a higher impact of headaches on daily activities.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Overall Satisfaction of Patients
Patients will be asked whether they would recommend Introvision for headache patients and can choose between "yes" or "no". The number of patients responding "yes" is reported.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session