2026-06-01T04:21:46Zhttps://riuma.uma.es/rest/oai/request

oai:riuma.uma.es:10630/308102026-02-03T10:53:28Zcom_10630_2254col_10630_37953

Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA) De la Vega, Rocío Serrano-Ibáñez, Elena Rocío Ruiz-Párraga, Gema Teresa Palermo, Tonya M. Wicksell, R.W. Fernández-Jiménez, Eduardo Oliva-Rodríguez-Pastor, Silvia Roldán, Susana Monfort, Laura Peláez, María José Carmona Leyva, Moisés Ramírez-Maestre, María del Carmen López-Martínez, Alicia Eva Miró, Jordi Esteve-Zarazaga, Rosa Dolor - Aspectos psicológicos Adolescentes - Psicología Salud - Innovaciones tecnológicas Background: Children and adolescents with chronic pain are a vulnerable population who often lack the resources to manage their condition. Due to high personal, social, and economic consequences, proper management in its early stages is key to reducing disability. The aim of this project is to co-develop a digital intervention for pediatric chronic pain (Digital SPA) with end-users and to evaluate its effectiveness and implementation outcomes in Spain. Methods: (Phase 1) Focus groups with patients, parents, and clinicians (n=5–6 each) will inform about unmet pain care needs and provide a starting point for co-designing the intervention. (Phase 2) Content creation and usability testing will be based on the results of Phase 1, and the theory-driven development will follow the latest available evidence. The intervention will use validated psychological techniques focused on improving functioning by teaching pain coping skills. (Phase 3) Hybrid effectiveness– implementation trial. Participants (n=195) will be adolescents aged 12–17 years old with chronic pain and one of their parents. Assessments include physical function, pain, sleep, anxiety, mood, satisfaction and adherence to the treatment, and number of visits to the emergency room. A qualitative framework analysis will be conducted with data from Phase 1. Effects of the intervention will be evaluated using linear multilevel modeling. The Consolidated Framework for Implementation Research (CFIR) and Behavioral Interventions Using Technology (BIT) frameworks will be used to evaluate implementation. Discussion: This study is expected to produce a co-created evidence-based digital intervention for pediatric chronic pain and a roadmap for successful implementation. Trial registration number 2024-03-12T10:42:34Z 2024-03-12T10:42:34Z 2024-03-12T10:42:34Z 2023-12-19 journal article 1. de la Vega R, Serrano-Ibáñez ER, Ruiz-Párraga GT, et al. Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness–implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA). DIGITAL HEALTH. 2023;9. https://hdl.handle.net/10630/30810 10.1177/20552076231219490 eng http://creativecommons.org/licenses/by-nc-nd/4.0/ open access Attribution-NonCommercial-NoDerivatives 4.0 Internacional