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NOT YET RECRUITING
NCT07337343

Co-Development and Validation of Colonic Symptom Pictograms for Young People

Sponsor: University of Auckland, New Zealand

View on ClinicalTrials.gov

Summary

Severe constipation affects 10% of children, often leading to significant physical and emotional distress. While constipation is commonly associated with impaired bowel movements, it is fundamentally linked to abnormalities in colonic motility - the coordinated contractions that facilitate passage of stool through the colon and out of the body. Diagnosis of constipation is based upon the Rome IV criteria, which assess symptoms as reported or remembered over the previous 3 months. However, reporting symptoms experienced can be challenging for children and young people for many reasons, such as the overlap of sensations, including fullness, bloating, and discomfort, and an inability to recall or precisely distinguish and describe what they are feeling. This study intends to design, develop, and validate symptom pictograms for children aged 8-17 with colonic or lower gut symptoms.

Key Details

Gender

All

Age Range

8 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2026-01-01

Completion Date

2027-04-01

Last Updated

2026-01-13

Healthy Volunteers

Yes

Interventions

OTHER

Pictogram comprehension and validation

This study aims to codesign and validate Colonic Symptom Pictograms for use with Young People to support them in distinguishing and reporting the symptoms they experience.