Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients
- Conditions
- Chronic Pain
- Interventions
- Behavioral: Digital SPA
- Registration Number
- NCT05917626
- Lead Sponsor
- University of Malaga
- Brief 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 (adolescents) or a website (parents).
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 195
- 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)
- Diagnosis of a comorbid serious health condition (e.g., cancer)
- Parent or child does not speak or read Spanish
- Active psychosis or suicidal ideation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Digital SPA Digital SPA A psychological intervention for chronic pain in adolescents administered using an app co-created with patients.
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Satisfaction with treatment Post-treatment (T3; 8 weeks after T1). The Treatment Evaluation Inventory will be administered. It ranges from 0 to 35, with higher scores indicating more satisfaction with the treatment.
Change in pain readiness to change 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). Readiness to adopt a self-management approach to pain. The Spanish version of the Pain Stages of Change Questionnaire for Adolescents (PSoCQ-A). The Questionnaire has three scales: Pre-contemplation, Contemplation, and Action/Maintenance. Each scale is scored in a 1 to 5 Likert scale, with higher scores indicating a higher level of attitudes in that stage of change. The scale with the highest score indicates which stage the respondent is at.
Change in Emotional Distress 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 Spanish version of the Patient-Reported Outcomes Measurement Information System (PROMIS) emotional distress scale will be administered to assess anxiety and depression symptoms. The anxiety scale is scored in a 1 ("never") to 5 ("always") scale, with higher scores indicating more anxiety symptoms. The depression scale is scored in a 1 ("never") to 5 ("always") scale, with higher scores indicating more depression symptoms.
Change in Sleep 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). Sleep quality will be assessed with the Spanish version of the Pittsburgh Sleep Quality Index, validated for adolescents (PSQI). Scores on 7 components range from 0 to 3, and are the summed (global score range 0 to 21, with higher scores indicating worse sleep quality).
Insomnia will be assessed with the Spanish version of the Adolescent Insomnia Questionnaire (AIQ). Total scores range from 0 to 52 with higher scores indicating more insomnia symptoms.Change in Self-efficacy Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3). Self-Efficacy Questionnaire for Children (SEQ-C). The perception of self-management skills after treatment will be assessed with this questionnaire. Each item has to be scored on a 5-point scale between 1 "not at all" and 5 "very well". Total scores range from 21 to 105, with higher scores indicating more self-efficacy.
Change in the dose of pain medication taken 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 dose (eg. 25 mg per day) of pain medication taken will be recorded.
Change in the type of pain medication taken 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 type (e.g. Non-steroid Anti-inflammatory Drugs, opioids) of pain medication taken will be recorded.
Change in Functional Disability 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 Spanish version of the Functional Disability Inventory for adolescents (FDI) will be administered. 0 "No trouble" to 4 "Impossible". The total FDI score can range from 0 to 60, with higher scores indicating higher levels of disability.
Adherence to treatment From the moment the treatment app is downloaded (T1), to the completion of the treatment period (T3). Up to 10 weeks. One measure of implementation will be adherence to the online intervention assessed collecting back-end data such as: number of log-ins or number of treatment sections completed.
Trial Locations
- Locations (6)
Hospital Materno Infantil Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Sant Joan de Déu
🇪🇸Barcelona, Spain
Hospital Materno Infantil Torrecardenas
🇪🇸AlmerÃa, Spain
Hospital Materno Infantil del Hospital Regional Universitario
🇪🇸Málaga, Spain
Hospital General Universitario Santa LucÃa
🇪🇸Cartagena, Murcia, Spain
Hospital infantil del Hospital Universitario La Paz
🇪🇸Madrid, Spain