Trial document




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  DRKS00003308

Trial Description

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Title

MUKIS - Munich analysis of headaches in highschool students - intervention study

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Trial Acronym

MUKIS

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URL of the Trial

http://www.dmkg.de/mukis

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Brief Summary in Lay Language

Headaches belong to the most prevalent health problems. They lead to a reduction in the quality of life and can account for the development of psychic diseases. Headaches in youth can become a lifelong burden through chronic manifestation. Risk factors for headaches were identified. Avoiding these risk factors (e. g. high consumption of alcoholics and coffein, physical inactivity, daily smoking) and acquiring stress coping strategies can probably decrease the prevalence of headaches. Recently, it was shown in a Norwegian study that already a low level intervention can reduce the prevalence of headaches. We developed an one hour headache counselling including practical exercises especially for youth based on the results of our previous study. This will be carried out in classes at Munich highschools. The Ministry of the State of Bavaria for Education and Cult, Germany, has approved the evaluation of this intervention as a cluster-randomised study within the highschool year 2011/12 on 01 August 2011. The goal of the study is to investigate the effectivity of this low level prevention strategy.

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Brief Summary in Scientific Language

A cluster-randomised study to assess the effectiveness of a low level intervention to prevent headaches in youth was designed. The basic elements of the intervention are: counselling about preventable risk factors for headaches, acquirement of coping competencies for stress and instructions for exercises to relax the neck muscles. The study will be conducted with highschool students of the 8th until 10.eh grade in the area of Munich, Germany. The randomisation will be done according to the grades.

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Organizational Data

  •   DRKS00003308
  •   2011/11/07
  •   [---]*
  •   yes
  •   Approved
  •   356-11, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G43 -  Migraine
  •   G44.2 -  Tension-type headache
  •   G44 -  Other headache syndromes
  •   R51 -  Headache
  •   R42 -  Dizziness and giddiness
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Interventions/Observational Groups

  •   Intervention group (intervention as headache counselling at the beginning of the study)
  •   Control group (intervention/headache counselling at the end of the study)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Prevention
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

Change of the headache prevalence among highschool pupils with versus without intervention. Investigation of the headache prevalence according to the criteria of the International Headache Society (IHS) via written questionnaire; time of measurement: right before the intervention (first survey) and at least 6 months afterward (second survey)

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Secondary Outcome

Change of the prevalence of the consumption of alcohol and coffein, physical activity, (daily) smoking and muscle tension of the neck via established written questionnaire (among other things extracts of Beschwerden-Liste von Zerssen, SSCS from TICS); time of measurement: right before the intervention (first survey) and at least 6 months afterward (second survey)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/11/10
  •   1286
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Pupils from the 8th until 10th grade at public highschools in Munich; existence of informed consent (from parents and in case of the age of 14 years and older additional from pupils themselves)

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Exclusion Criteria

Pupils from private highschools in Munich; pupils who are not able to answer the written questionnaire by themselves and who are not able to understand and to realize the intervention due to psychic or physical diseases

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Addresses

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    • Institut für Soziale Pädiatrie und Jugendmedizin der Ludwig-Maximilians-Universität München, Abteilung für Epidemiologie im Kindes- und Jugendalter
    • Mr.  Prof. Dr. med.  Rüdiger  von Kries 
    • Heiglhofstr. 63
    • 81377  München
    • Germany
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    • Institut für Soziale Pädiatrie und Jugendmedizin der Ludwig-Maximilians-Universität, Abteilung für Epidemiologie im Kindes- und Jugendalter
    • Mr.  Prof. Dr. med.  Rüdiger  von Kries 
    • Heiglhofstr. 63
    • 81377  München
    • Germany
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    • Institut für Soziale Pädiatrie und Jugendmedizin der Ludwig-Maximilians-Universität, Abteilung für Epidemiologie im Kindes- und Jugendalter
    • Ms.  Dipl. Med.-Päd.  Steffi  Lehmann 
    • Heiglhofstr. 63
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Soziale Pädiatrie und Jugendmedizin der Ludwig-Maximilians-Universität München, Abteilung für Epidemiologie im Kindes- und Jugendalter
    • Mr.  Prof. Dr. med.  Rüdiger  von Kries 
    • Heiglhofstr. 63
    • 81377  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/07/27
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.