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 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
Sequential
Digital SPA
BehavioralA 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.
Change in Pain Interference
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
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
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).
Change in pain readiness to change
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 the dose of pain medication taken
The dose (eg. 25 mg per day) of pain medication taken will be recorded.
Change in the type of pain medication taken
The type (e.g. Non-steroid Anti-inflammatory Drugs, opioids) of pain medication taken will be recorded.
Change in Emotional Distress
The Spanish version of the Social Emotional Distress Scale-Secondary (SEDS-S) will be administered to assess general emotional distress (internalizing symptoms such as anxiety and depression) over the past month. The SEDS-S is a 10-item self-report questionnaire; items are rated from 1 ("Not at all true") to 4 ("Very true / Absolutely true"), with higher total scores indicating greater emotional distress.
Adverse Events (side effects)
Adverse Events are not expected given the content of the treatment and its non-invasive nature, however, they will be assessed, recorded and controlled for in the analyses
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University of Malaga
Lead sponsor
Ministerio de Ciencia e Innovación, Spain
Collaborator
