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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-17
SponsorUniversity of Auckland, New Zealand

About this trial

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.

Eligibility criteria

Qualifiers

have lower gut or constipation symptoms,

can communicate in English or be supported to participate by a caregiver, whānau, or other responsible person. Phase Four will include international invitations to participants with lower gut or constipation symptoms. Healthy volunteers will not be recruited.

Disqualifiers

Children and Young people with developmental or cognitive disorder that precludes their ability to understand the study,

Children and Young people who do not have access to a digital device with internet connectivity,

unable to read English,

parent does not consent

Trial design

Treatments tested in this trial

  • Pictogram comprehension and validation

Treatment groups

120 Participants
are divided into 1 treatment group

Locations

This trial has no locations