An observational study in Constipation - Functional, Abdominal Pain (AP) and Nausea and Vomitting, sponsored by University of Auckland, New Zealand. Not yet recruiting. Open to participants aged 8 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by University of Auckland, New Zealand · Observational
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.
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:
A multi-phase, mixed-methods study incorporating participatory co-design, iterative prototyping, and validation testing with children and young people aged 8-17 years.
Study Population Children and young people aged between 8-17-years with and without lower gastrointestinal symptoms.
Participant Numbers Phase One: A review of current guidelines and symptom questionnaires to confirm core colonic symptoms relevant to refractory constipation, and a web-based search for images depicting these symptoms to identify common concepts. Final selection will be confirmed by the research team and clinical advisors.
Phase Two: Co-design. A minimum of 30 children and young people.
Phase Three: Pictogram Development and Refinement based on Phase I, and check the designs for clarity with a group of young people before the validation phase.
Phase Four: Validation: At least 80 children and young people with and without lower gastrointestinal symptoms such as constipation.
Inclusion Criteria For all phases, the main inclusion criteria for all children and young people participants are that they are,
Criteria for Evaluation Phase One: Thematic analysis of symptom concepts and visual ideas, and identification of the symptoms that will be designed and presented visually
Phase Two: Gather pictures of symptoms drawn by young people. Review of symptom concepts drawn by participants, reviewing differences and similarities by different ages, sex, and ethnicity (as appropriate), such as facial expressions, colours, and prompts used. Design new colonic symptom pictograms that reflect the outcome of Phases One and Two.
Phase Three: Confirm the clarity and qualitative feedback on preferred styles and features of the new pictograms.
Phase Four: Following ISO standard 9186, Comprehension Validity (translucency and transparency) and content validity index metrics, the pictograms will be evaluated for understanding and agreement and validated against existing tools.
Statistical Methods Phases Two and Three: A convenience sample will be adopted, so no power analyses have been calculated.
Phase Four: The proposed minimum of 80 participants is expected to be sufficient to test the guessability, translucency, and validity of six to ten pictograms and provide precision about the mean and variance for the consistency, reliability, and construct validity. (Boateng et al. 2018)
Analysis Phase One: A review of common themes, symptom concepts, and visual ideas will be used to identify the relevant symptoms that need to be co-designed.
Phase Two: A review of the common themes, images, and prompts to enable new pictograms to be designed and developed
Phase Three: A review of the responses for each symptom pictogram recognition and understanding.
Phase Four: Descriptive and comparative statistics will be utilised. Translucency will be assessed using a visual analogue scale, ranging from 0 (complete lack of correlation) to 5 (very high correlation agreement). Achieving an agreement of ≥3 is identified as an acceptable level of correlation between the pictogram and its meaning. Validity will be evaluated using the Content Validation Index (CVI) and Pearson's correlation coefficient equations, with internal reliability assessed using Cronbach's α. A CVI greater than 80% and a coefficient level above 0.65 are acceptable.
387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.
This study's planned enrollment of 120 is close to the median of 127 across 80 observational studies indexed under Abdominal Pain.
Browse Abdominal Pain studies →University of Auckland, New Zealand is the lead sponsor of 57 studies on the registry; 13 are open to participants now.
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International cohort of young people aged 5-17 years
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children and Young people are aged between 8-17 years,
Exclusion Criteria:
children and young people aged 8-17 years with lower GI symptoms
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.
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,
No study locations are listed for this record.
Plan to share: No — During the study, data may be collected from participants who identify, for example, as Māori (indigenous population of New Zealand). Providing insights and information to research is a tāonga (treasure) and will be treated accordingly. The research team aims to ensure data sovereignty in light of, for example, the global directives on Indigenous rights and local treaties such as Te Tiriti o Waitangi in Aotearoa/New Zealand. We will not routinely make IPD data available. However, we will consider requests where the proposal meets international guidelines to ensure that datasets are analysed according to the data governance of the respective cultures, such as Tikanga Māori in New Zealand.
No publications or documents are linked to this record.
Start is estimated for Jan 2026; primary completion for Jan 2027, 12 months later.
Of 28 non-industry observational studies under Abdominal Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 38. This study's planned 12 months is below that.
Counting every sponsor, half of 37 studies reached it within 16 months; a quarter within 7 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of Auckland, New Zealand