Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12. Each patient is treated with NPB. No placebo group is established. Course and severity of symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS). A standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.
Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12. Patients and methods: A prospective, non-interventional, non-randomized, observational study conducted in German pediatric practices. Each patient is treated with NPB. No placebo group is established. As subjective criteria to document course and severity of symptoms, a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS) is used. As an objective criterion, a standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.
Study Type
OBSERVATIONAL
Enrollment
115
multiple German Paediatric Practices
Giessen, Hesse, Germany
Change in Parent Child Behaviour Checklist (CBCL/4-18)
Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire
Time frame: after 2 + 4 weeks´ treatment
Tolerability of NEURAPAS balance
kind, frequency, duration, outcome of ADR
Time frame: after 2 + 4 weeks
Change of 13 common symptoms of nervous restlessness
Questionnaire on 13 common symptoms of nervous restlessness in children
Time frame: after 2 + 4 weeks
Change of the impact of the child´s complaints on daily family life (VAS)
Visual Analogue Scale (VAS)to assess the impact of the child´s complaints on daily family life
Time frame: after 2 + 4 weeks
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