NCT00010933

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2001

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

February 2, 2001

Last Update Submit

August 16, 2006

Conditions

Recurrent Abdominal Pain

Interventions

chamomile teaDRUG
Relaxation/Guided ImageryPROCEDURE

Eligibility Criteria

Age0 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with Recurrent Abdominal Pain (RAP), as defined by the 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
  • Patients with Irritable Bowel Syndrome (IBS) defined by a similar pattern of abdominal pain as for RAP patients, and relieved by defecation and/or associated with altered bowel habits and/or stool consistency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona, Department of Pediatrics, Health Sciences Center

Tucson, Arizona, 85724-5073, United States

Location

MeSH Terms

Conditions

Abdominal Pain

Interventions

Chamomile extractImagery, Psychotherapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Fayez K. Ghishan

    University of Arizona, Department of Pediatrics, Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 2, 2001

First Posted

February 5, 2001

Study Start

September 1, 1998

Study Completion

June 1, 2004

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)