Trial document





This trial has been registered retrospectively.
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  DRKS00011736

Trial Description

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Title

Influence of structured follow up in First seizure clinic on anxiety of parents and children after first, unprovoked seizure- a randomized, controlled pilot study

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Trial Acronym

FSC pilot

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Unprovoked seizures are a common symptom in childhood. There is not much information about parental anxiety and anxiety of the child due to the seizure. Especially, there are no study looking at the influence of a structured follow up (e.g. Fist seizure clinic) on anxiety. With this current study, we want to show how anxiety of child and parents develop within 12 month after a first unprovoked seizure and how this anxiety can be influenced by a structured follow up program.

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Brief Summary in Scientific Language

Studys on parental anxiety after a febrile seizure of their child showed a relevant anxiety. However, there are limited data on anxiety in patients and their parents after a first unprovoked seizure. The key point of this study is, to look at parental anxiety and anxiety of the child in a randomized, prospective setting, to evaluate the influence of a structered follow up within 4 weeks after the seizure compared to a follow up within 4 month.

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Organizational Data

  •   DRKS00011736
  •   2017/07/26
  •   [---]*
  •   yes
  •   Approved
  •   474/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   R56.8 -  Other and unspecified convulsions
  •   Epileptic seizure
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Interventions/Observational Groups

  •   FSC: First seizure group: Follow up within 3 weeks after seizure.
  •   SC: standard care group: follow up within 3 month as it is current standard of care.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Parental anxiety and anxiety of patient at time 0 (=seizure), 4 and 12 month later. Anxiety is measured with the STAI (state trait anxiety inventory)

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/02/13
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   4   Weeks
  •   18   Years
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Additional Inclusion Criteria

1. Presenting with first unrovoked seizure2. age 4 weeks to 18 years
3. Signed informed consent

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Exclusion Criteria

1. Febrile seizures: Temperature of 38,5°C and above within 6 hours before and after the seizure
2. Previous presentation with same or similar symptoms. 3. More than one seizure within 12 month
4. Admission to hospital within 12 month

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Addresses

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    • Klinik für Neuropädiatrie und Muskelerkrankungen, Zentrum für Kinder- und Jugendheilkunde des Universitätsklinikums Freiburg
    • Ms.  Dr. med.  Kerstin Alexandra  Klotz 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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    • Klinik für Neuropädiatrie und Muskelerkrankungen, Zentrum für Kinder- und Jugendheilkunde des Universitätsklinikums Freiburg
    • Ms.  Dr. med.  Kerstin Alexandra  Klotz 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Klinik für Neuropädiatrie und Muskelerkrankungen, Zentrum für Kinder- und Jugendheilkunde des Universitätsklinikums Freiburg
    • Ms.  Dr. med.  Kerstin Alexandra  Klotz 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Neuropädiatrie und Muskelerkrankungen, Zentrum für Kinder- und Jugendheilkunde des Universitätsklinikums Freiburg
    • Ms.  Dr. med.  Kerstin Alexandra  Klotz 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.