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

This trial accepts healthy volunteers

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 population

International cohort of young people aged 5-17 years

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pictogram comprehension and validation

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: children and young people aged 8-17 years1 intervention

Trial outcomes

Primary outcomes

1

Validation of each Pictogram

We hypothesize that the new colonic pictogram-based symptom reporting will demonstrate equivalent or superior validity and reliability compared to traditional questionnaire-based methods for reporting constipation symptoms in young people. Specific analyses will be to evaluate the pictograms for comprehension, translucency, face validity, construct validity, and convergent and divergent validity. * Comprehension: responses will be measured using a scale from 1= correct , 4= correct and 5 = did not answer. * Translucency: Likert rating scale to report how well participants report the pictograms reflect the intended symptoms Convergent: Using Rome IV Section B responses will be compared to the correct pictogram to assess correlations Divergent: A lower relationship between pictogram comprehension and PedsQL Oral Health questionnaire will be assessed Concurrent: PedQL answers will assess the association between accruated identifying the pictograms and health outcomes

Time frame
Analyses will be undertaken once the last participant (80th) has completed the online survey. This is anticipated to occure 6 months fro start of the study,

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: