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

NCT07337343 | Not Yet Recruiting

• 1 other identifier: Colonic_Pictogram_Val
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Constipation - Functional; Abdominal Pain (AP); Nausea and Vomitting; Bloating; Flatulence; IBS, Constipation Predominant

Keywords

children and adolescents; pictograms; co-design; validation

Outcome Measures

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

  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,

Study Arms (1)

children and young people aged 8-17 years

children and young people aged 8-17 years with lower GI symptoms

Other: Pictogram comprehension and validation

Interventions

Pictogram comprehension and validation OTHER

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.

children and young people aged 8-17 years

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

International cohort of young people aged 5-17 years

You may qualify if:

• Children and Young people are aged between 8-17 years,
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Auckland, New Zealand: lead

MeSH Terms

Conditions

Abdominal Pain; Nausea; Flatulence; Ichthyosis Bullosa of Siemens

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Gayl Humphrey, PhD

CONTACT

+64 211100901; g.humphrey@auckland.ac.nz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share