Study of a Smartphone App to Help Manage Chronic Pain in Adolescents Ages 12 to 17 Co-designed With Patients and Their Parents for Improved Pain Care

What this Trial Is About

Researchers are evaluating a smartphone app called Digital Solution for Pain in Adolescents Digital SPA designed to help children and adolescents aged 12 to 17 years who have chronic pain. This study aims to co-develop the app with patients, test its usability, and implement it as a tool to provide pain management resources and prevent future disability. The study is divided into multiple phases including focus groups, content creation, and an effectiveness and implementation study. The intervention uses validated psychological methods, especially Cognitive Behavioral Therapy and Acceptance and Commitment Therapy, to teach pain coping skills such as relaxation, goal setting, sleep management, behavioral activation, self-management of negative thoughts and emotions, and communication skills. Participants will be randomly assigned to either use the Digital SPA app or receive usual care at their hospital. The app was co-created with patients based on their input and current evidence-based guidelines. Participants will take part in individual and group interviews, complete online questionnaires, and use the smartphone app during the study. Researchers will measure changes in pain interference, emergency room visits due to pain, pain readiness to change, medication use, emotional distress, functional disability, sleep quality, pain self-efficacy, psychological flexibility, treatment satisfaction, and adherence over several time points from before treatment, mid-treatment, post-treatment, and at a 3-month follow-up. The total study duration includes an 8-week treatment period and follow-up assessments at 3 months after treatment completion.

Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients