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

Condition(s) studied

Investigational drug(s) / intervention(s)

Digital SPA: A psychological digital intervention for chronic pain in adolescents, based on evidence-based Acceptance and Commitment Therapy techniques. The intervention will be co-created with patients in a previous phase of the study, so the exact number or format of sessions and content has not been determined yet.

Study summary

Children and adolescents with chronic pain often lack a proper diagnosis and treatment. Research has shown that, if left untreated, it usually doesn't resolve and continues through adulthood.

The goal of this multi-phase study is to co-develop (with patients), test, and implement a smartphone app called "Digital Solution for Pain in Adolescents" (Digital SPA) which can provide pain management resources to children with chronic pain and their parents, preventing future disability.

Participants will: participate in individual and group interviews, respond to questionnaires online and try a smartphone app.

Eligibility

Primary outcome measure(s)

• Change in Pain Interference — Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
  Spanish version of the Brief Pain Inventory (BPI) short version. Pain intensity scale scores range from from 0 to 10 , with higher scores indicating greater interference. Interference scores range from 0 to 10, with higher scores indicating greater interference.
• Global impression of change after treatment — Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
  11-point scale (0 to 10) with higher scores indicating greater impression of change.
• Change in the number of visits to the Emergency Room (ER) due to pain — Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
  The number of visits to the ER due to pain during the follow-up period (T3 to T4; 3 months) will be compared with the three months before starting treatment (T1).

Trial sites (6)

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