NCT Number: NCT05917626
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.
Interested in participating?
Request Info12 year–17 year
All sexes
Interventional
Not applicable
Hospital Materno Infantil Torrecardenas, Almería, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 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.
Time frame: 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 CALI-9. Disability in functioning due to pain (activity limitations) is measured through 9 items to evaluate pain-related activity limitations in youth with chronic pain. Scores range from 1 = not very difficult; to 5 = extremely difficult. Higher scores indicating greater interference with children's activities.
Time frame: 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.
Time frame: Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Pain self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ). The PSEQ is a 10-item self-report measure that evaluates the extent to which individuals feel capable of functioning despite their pain. Items are rated on a 7-point scale from 0 ("not at all confident") to 6 ("completely confident"). Total scores range from 0 to 60, with higher scores indicating greater pain-related self-efficacy.
Time frame: 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).
Psychological flexibility and inflexibility will be assessed using the Multidimensional Psychological Flexibility Inventory (MPFI). The MPFI includes subscales capturing both flexibility and inflexibility across six ACT processes. Items are rated on a 1 ("never true") to 6 ("always true") scale. Subscale scores are computed by summing item responses, with higher scores indicating greater levels of the corresponding process (higher flexibility or higher inflexibility). A global index of psychological flexibility will also be measured using the PsyFlex questionnaire. The PsyFlex consists of 6 items rated on a 1 ("very untrue of me") to 5 ("very true of me") scale. Total scores range from 6 to 30, with higher scores indicating greater psychological flexibility.
Time frame: Post-treatment (T3; 8 weeks after T1).
Usability and satisfaction with the intervention will be assessed using the mHealth App Usability Questionnaire (MAUQ). The MAUQ includes 18 items rated on a 1 ("strongly disagree") to 7 ("strongly agree") scale. Subscales assess ease of use, interface and satisfaction, and usefulness. Higher scores indicate greater usability and satisfaction with the digital intervention.
Time frame: 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.
Time frame: Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
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
Contact information is provided by the study sponsor or research team.
University of Malaga
Other
Acronym: Digital SPA
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