Mobile app improves treatment of functional constipation in children: a randomized single-blind study

Abstract

Background: Functional constipation is one of the most prevalent functional gastrointestinal disorders in the pediatric population, frequently resulting in quality of life impairment and elevated healthcare costs. Despite the availability of evidence-based treatment guidelines, adherence remains an essential challenge to achieving sustained therapeutic success. Methods: This randomized, single-blind per-protocol study assessed the efficacy of a mobile application compared to conventional printed educational materials in supporting the management of functional constipation in children aged 4–12 years. 100 patient–caregiver dyads were randomized into two arms: an intervention group using a mobile application and a control group receiving printed recommendations. Clinical outcomes were evaluated over a six-month follow-up using the Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms Module. Results: There were 113 complete questionnaires, 65 from adults and 48 from children. Participants in the intervention cohort demonstrated significantly greater improvements in symptom control (mean difference 21.4 vs. 12.3 points; p = 0.014), particularly in the domains of constipation, abdominal pain, and bloating. Conclusions: The mobile application’s interactive features, behavioral tracking tools, and integrated reward system appeared to enhance adherence and self-efficacy among users. Overall, the results support the potential utility of mobile health interventions as adjuncts to standard care in managing pediatric functional constipation. Trial Registration: ClinicalTrials.gov NCT07025135. Registered 17/06/2025 (trial start 05/02/2023). Trial registration: ClinicalTrials.gov NCT07025135. Registered 17/06/2025 (trial start 05/02/2023).