Co-Development and Validation of Colonic Symptom Pictograms for Young People
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Validation of each Pictogram
Study Overview
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.
Detailed Description
Severe refractory 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 an overlap of sensations, such as fullness, bloating, and discomfort, and an inability to recall or precisely distinguish and describe what they are feeling. An earlier study approved by the New Zealand Health and Disability Ethics Committee (HDEC reference 2022 FULL 12705) designed, developed, and validated a set of upper gastric symptom pictograms to help children and young people record their symptoms during a test called body surface gastric mapping (BSGM). The use of these symptom pictograms has enabled improved correlation of gastric activity with symptoms to assist in the diagnostic process.
This study intends to build on this knowledge and apply it to design, develop, and validate symptom pictograms for children aged 8-17 with colonic or lower gut symptoms.
Objective To co-design, develop, and validate a set of pictograms representing lower gastrointestinal (GI) symptoms that are easily understood and useful for children and young people aged 8-17 years. The pictograms will support improved symptom communication, enhance clinical assessment, and be evaluated for comprehension, acceptability, and utility during investigations.
Study Design and Methodology:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 8 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
children and young people aged 8-17 years
children and young people aged 8-17 years with lower GI symptoms
Intervention: Pictogram comprehension and validation (Other)
Outcomes
Primary Outcomes
Validation of each Pictogram
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,
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Gayl Humphrey
Dr
University of Auckland, New Zealand