Pain smart: Integrating pain education and individualised support for adolescents with pain at schools. Protocol for a cluster randomised controlled trial

Introduction: Chronic pain is prevalent and impactful among adolescents. Unlike other health concerns affecting adolescents, school-based initiatives educating adolescents about pain are lacking. The Pain Smart clinical trial aims to estimate the effectiveness of a school-based pain education program in improving adolescents' understanding of pain. Methods and analysis: A cluster randomised controlled trial including 30 secondary schools (grades 7–10, ages 12–16) in New South Wales, Australia. Schools will be randomised (1:1) to receive the Pain Smart education module, or no intervention. The Pain Smart education module includes (i) three curriculum-aligned lessons about pain aligned with the biopsychosocial model, (ii) teacher training and (iii) caregiver resources. Students will complete online self-report surveys at baseline, 3- and 12-months. The primary effectiveness outcome will be mean difference between groups in pain understanding at 3 months, assessed by the Pain Concepts Questionnaire (PCQ). Process outcomes are teacher-rated acceptability, appropriateness, and feasibility. Continuous data will be summarised with measures of central tendency, and categorical data with counts and proportions. A linear mixed model will be used to estimate the mean difference between groups for all outcome measures. The analysis will be completed using all available data under the intention-to-treat approach, with α = 0.05. Ethics approval has been obtained from the University of Sydney (2024-HE001722). Implications: These findings will indicate if school-based pain education is effective in improving students' understanding of pain. This will inform future research including wide-scale implementation and directions for future iterations of school-based pain interventions. Trial registration: Australia New Zealand Clinical Trials Registry (ACTRN12625000793415), 25/07/2025. © 2026 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC license. http://creativecommons.org/licenses/by-nc/4.0/