RT Journal Article
T1 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)
A1 De la Vega, Rocío
A1 Serrano-Ibáñez, Elena Rocío
A1 Ruiz-Párraga, Gema Teresa
A1 Palermo, Tonya M.
A1 Wicksell, R.W.
A1 Fernández-Jiménez, Eduardo
A1 Oliva-Rodríguez-Pastor, Silvia
A1 Roldán, Susana
A1 Monfort, Laura
A1 Peláez, María José
A1 Carmona Leyva, Moisés
A1 Ramírez-Maestre, María del Carmen
A1 López-Martínez, Alicia Eva
A1 Miró, Jordi
A1 Esteve-Zarazaga, Rosa
K1 Dolor - Aspectos psicológicos
K1 Adolescentes - Psicología
K1 Salud - Innovaciones tecnológicas
AB Background: Children and adolescents with chronic pain are a vulnerable population who often lack the resources to managetheir condition. Due to high personal, social, and economic consequences, proper management in its early stages is keyto 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 needsand provide a starting point for co-designing the intervention. (Phase 2) Content creation and usability testing will be based onthe results of Phase 1, and the theory-driven development will follow the latest available evidence. The intervention will use validatedpsychological 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 ofvisits to the emergency room. A qualitative framework analysis will be conducted with data from Phase 1. Effects of the interventionwill be evaluated using linear multilevel modeling. The Consolidated Framework for Implementation Research (CFIR) andBehavioral 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 anda roadmap for successful implementation.Trial registration number
YR 2023
FD 2023-12-19
LK https://hdl.handle.net/10630/30810
UL https://hdl.handle.net/10630/30810
LA eng
NO 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.
NO This work was supported by the Ministerio de Ciencia eInnovación (grant number PID2021-122885OA-I00). RV’s workis supported by the Spanish Ministry of Science and Innovationwith a Ramon y Cajal contract (RYC2018-024722-I).
DS RIUMA. Repositorio Institucional de la Universidad de Málaga
RD 20 ene 2026