Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea
Condition: Functional Nausea
MeSH terms: Nausea
Study type: Interventional

Summary: 
      Functional gastrointestinal disorders are common disorders that are characterized by
      persistent and recurring GI symptoms. These occur as a result of abnormal functioning of the
      GI tract and are not caused by structural or biochemical abnormalities. As a result, medical
      tests- such as blood tests and endoscopic exams- have essentially normal/negative
      (non-disease) results. More than 20 functional GI disorders have been identified. They can
      affect any part of the GI tract. One of the most common functional disorders is nausea and
      dyspepsia (pain or discomfort in the upper abdominal area, feeling of fullness, bloating).
      Any chronic illness, including functional nausea, will affect a person's health-related
      quality of life (general well-being, ability to carry out everyday activities), additional
      psychosocial disturbances and amplify the experienced illness.

      The majority of children suffering from functional nausea in Europe are treated with
      Iberogast®. a herbal mixture, whose effect was demonstrated in several studies. Since
      Iberogast® is not available in the United States of America, children there receive an
      acupressure therapy. The American gastroenterologists refer hereby to several studies, which
      have shown, that the positive effect of such therapies in patients with chemotherapy-induced
      nausea is even greater than a therapy with ondansetron. Since acupressure is able to reduce
      somatic nausea, it is also believed to decrease functional nausea, but it has never been
      investigated. Therefore, there are no data. That's why Investigators want to compare the
      efficacy of these two therapies, that is, Iberogast® and acupressure
    

Detailed description: 
      Functional gastrointestinal disorders are common disorders that are characterized by
      persistent and recurring GI symptoms. These occur as a result of abnormal functioning of the
      GI tract and are not caused by structural or biochemical abnormalities. As a result, medical
      tests- such as blood tests and endoscopic exams- have essentially normal/negative
      (non-disease) results. More than 20 functional GI disorders have been identified. They can
      affect any part of the GI tract. One of the most common functional disorders is nausea and
      dyspepsia (pain or discomfort in the upper abdominal area, feeling of fullness, bloating).
      Any chronic illness, including functional nausea, will affect a person's health-related
      quality of life (general well-being, ability to carry out everyday activities), additional
      psychosocial disturbances and amplify the experienced illness.

      However, the majority of children suffering from functional Nausea in Europe get treated with
      Iberogast®: A herbal mixture, whose effect was demonstrated in several studies [10, 11].
      Since Iberogast® is not available in the United States of America, children receive there an
      acupressure therapy. The American gastroenterologists refer hereby to several studies, which
      have shown, that the effect of such therapies in patient with chemotherapy-induced nausea is
      even greater than the taking of ondansetron [12,13 ]. Since acupressure is capable to reduce
      somatic nausea, it is also believed to decrease functional nausea, but it has never been
      investigated, therefore no data are available. That's why Investigators plan to compare the
      efficiency of these two therapies.

      Furthermore Investigators want to measure the cognitive performance before and after the
      intervention to proof a possible effect on the 'gut-brain-axis'. For this purpose the
      participants have to do the 'Flanker Task', a standardised test on the computer.
    

Intervention name(s): Acupressure; Placebo-band; Iberogast; Placebo-drops
Intervention type(s): Other; Other; Drug; Other
Intervention description(s): Children will have to wear a 'seasickness-band', which has the effect of acupressure; Children will have to wear a 'placebo-wristband'; Children will have to take Iberogast drops; Children will have to take placebo-drops
Other intervention name(s): Seasickness-Band
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Iberogast; Acupressure; gut-brain-axis