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

University of Malaga

Status: Enrolling

Conditions: Chronic Pain

Treatments: Behavioral: Digital SPA

Study type: Interventional

Funder types: Other

Identifiers

NCT05917626

PID2021-122885OA-I00

Details and patient eligibility

About

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.

Full description

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 and the World Health Organization guidelines on the management of chronic pain in children. The intervention will use validated psychological techniques (particularly Cognitive Behavioral Therapy and Acceptance and Commitment Therapy) focused on improving functioning by teaching pain coping skills, such as: relaxation, goal setting, sleep management, behavioral activation, self-management of negative thoughts and emotions, and communication skills.

Phase 3) Effectiveness and Implementation study. Participants (n = 195) will be adolescents 12-17 years old with chronic pain admitted into any of 6 large hospitals in Spain and one of their parents.

Enrollment: 195 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adolescents age 12-17 years
• Has had non-oncologic chronic pain for at least 3 months (e.g., abdominal pain, headache or musculoskeletal pain)
• Has Internet access
• One parent is willing to participate (and both give consent for their child to participate)

Exclusion criteria

• Diagnosis of a comorbid serious health condition (e.g., cancer)
• Parent or child does not speak or read Spanish
• Active psychosis or suicidal ideation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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195 participants in 2 patient groups

Digital SPA

Experimental group

Description:

A psychological intervention for chronic pain in adolescents administered using an app co-created with patients.

Treatment:

Behavioral: Digital SPA

Usual Care

No Intervention group

Description:

Participants assigned to this arm will receive usual care from their hospital.