Contemporary clinical trials · 2026
Pain Smart: Integrating pain education and individualised support for adolescents with pain at schools. Protocol for a cluster randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Bogard Isabelle, Kamper Steven J, Montgomery Laura R C, Williams Christopher M, Sortwell Andrew, Swain Michael S, Rogers Kris, Soussa Payton, Kilgour Sarah, Yamato Tiê P, Pain Smart Investigators
Аннотация
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.
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.