Treatment of Functional Abdominal Pain in Children: Evaluation of Relaxation/Guided Imagery and Chamomile Tea as Therapeutic Modalities
Condition: Recurrent Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate novel methods from CAM aimed at alleviating
      chronic pain related to functional bowel disorders in children. To that end, two CAM
      modalities will be investigated independently of each other, namely Guided Imagery and the
      use of Chamomile teas as a form of botanical therapy.

      Functional abdominal pain is defined as pain unrelated to an identifiable organic
      gastrointestinal disorder. The two subcategories of functional bowel disorders examined by
      this study will be RAP and IBS. The definition of RAP in children will follow Apley's classic
      definition of paroxysmal abdominal pain occurring in children between the ages of 4 and 16
      years that persists for more than three months, with a frequency of three or more episodes of
      abdominal pain over a three month interval. A similar pattern of abdominal pain relieved by
      defecation and/or associated with altered bowel habits and/or stool consistency will be
      defined as IBS. Despite the above definitions, note that the typical frequency of pain
      episodes associated with functional bowel disorders is at least three times per month.
    

Detailed description: 
      Functional bowl disorders are defined as variable combinations of gastrointestinal symptoms
      that are not readily explained by structural or biochemical abnormalities. In children, these
      typically encompass irritable bowel syndrome and recurrent abdominal pain of childhood, two
      closely related disorders that reflect similar pathophysiologic processes. Both of these
      functional disorders are pervasive in children and possibly precede symptoms that persist
      into adulthood. These also account for considerable medical expense and morbidity resulting
      in school absenteeism. Existing therapies are limited, and the lack of success frequently
      frustrates parents, families, and physicians. The purpose of this pilot project is to explore
      the use of alternative medicine modalities to treat functional abdominal pain relying on
      those that address currently accepted pathophysiologic models of functional bowel disorders.
      Available evidence indicates 3 major mechanisms for these syndromes: altered intestinal
      motility, altered intestinal sensory thresholds, and psychosocial factors. Recurrent
      abdominal pain occurs in 10 to 30 percent of children and adolescents, and evidence suggests
      that many children with recurrent abdominal pain ultimately develop symptoms compatible with
      irritable bowel syndrome in adulthood. As many as 68% of school children suffering from
      recurrent abdominal pain have symptoms compatible with the diagnostic criteria for irritable
      bowel syndrome in adults. Colonic motility studies suggest exaggerated colonic motor function
      in patients with abdominal pain compared to controls, increased perception of abdominal pain
      following balloon distention of the rectum, and anxiety and depression compared to healthy
      children in the community. The approach to therapy including reassurance, fiber, and
      antispasmodics has not been effective in the long-term management of a recurrent abdominal
      pain in childhood.

      Accordingly, this pilot project will attempt to evaluate objectively two alternative
      modalities that address some of the mechanisms and could offer therapeutic options. In
      specific aim 1, a randomized controlled trial will be instituted to confirm the effectiveness
      of relaxation/guided imagery as a modality for treating functional bowel disorders in
      children and determine if guided imagery improves outcome beyond that achievable using
      relaxation training alone. In the second trial, the use of chamomile tea as an adjunct to
      traditional modes of treating functional bowel disorders in children will be assessed and
      compared to controls who do not receive chamomile tea. The primary outcome will be a
      reduction in pain measured by a Likert-scale pain inventory using faces as markers. The
      advantages of this inventory are that faces have been found to be universal across
      ethnicities and age groups. Secondary outcomes will include bowel habits and stool
      consistency, measures of functional disability using the Functional Disability Index, and
      psychiatric profiles using the Child Depression Inventory, Revised Children's Manifest
      Anxiety Scale, and Children's Global Assessment Scale. In addition, compliance measures will
      be assessed by phone contact by nurse clinicians. Data management will be undertaken to
      quantify the analyses already described.
    

Intervention name(s): chamomile tea; Relaxation/Guided Imagery
Intervention type(s): Drug; Procedure
Allocation: Randomized
Masking: Double
Primary purpose: Treatment