Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients
NCT ID: NCT05917626
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
195 participants
INTERVENTIONAL
2023-05-05
2027-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
* Outcomes will be assessed with an online survey
Study Groups
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Digital SPA
A psychological intervention for chronic pain in adolescents administered using an app co-created with patients.
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.
Usual Care
Participants assigned to this arm will receive usual care from their hospital.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Parent or child does not speak or read Spanish
* Active psychosis or suicidal ideation
12 Years
17 Years
ALL
No
Sponsors
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Ministerio de Ciencia e Innovación, Spain
OTHER_GOV
University of Malaga
OTHER
Responsible Party
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Rocio de la Vega de Carranza, PhD
"Ramón y Cajal" Researcher; Principal Investigator
Principal Investigators
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Rocio de la Vega, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Malaga
Locations
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Hospital Materno Infantil Torrecardenas
Almería, Almería, Spain
Hospital Sant Joan de Déu
Barcelona, Barcelona, Spain
Hospital Materno Infantil Virgen de las Nieves
Granada, Granada, Spain
Hospital infantil del Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital General Universitario Santa Lucía
Cartagena, Murcia, Spain
Hospital Materno Infantil del Hospital Regional Universitario
Málaga, Málaga, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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de la Vega R, Serrano-Ibanez ER, Ruiz-Parraga GT, Palermo TM, Wicksell R, Fernandez-Jimenez E, Oliva S, Roldan S, Monfort L, Pelaez MJ, Leyva Carmona M, Ramirez-Maestre C, Lopez-Martinez AE, Miro J, Esteve R. 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). Digit Health. 2023 Dec 19;9:20552076231219490. doi: 10.1177/20552076231219490. eCollection 2023 Jan-Dec.
Related Links
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Project website
Other Identifiers
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PID2021-122885OA-I00
Identifier Type: -
Identifier Source: org_study_id
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