Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 12
- 主要终点
- Change in Pain Interference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
- Clinicians referring participants will be unaware of the study phase
- Outcomes will be assessed with an online survey
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Diagnosis of a comorbid serious health condition (e.g., cancer)
- •Parent or child does not speak or read Spanish
- •Active psychosis or suicidal ideation
结局指标
主要结局
Change in Pain Interference
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- 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).)
- Satisfaction with treatment(Post-treatment (T3; 8 weeks after T1).)
- Adherence to treatment(From the moment the treatment app is downloaded (T1), to the completion of the treatment period (T3). Up to 10 weeks.)
- 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).)
- 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).)
- 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).)
- 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).)
- 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).)
- 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).)
- 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).)
- 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).)
- 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).)
- 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).)
- 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).)
- Change in Pain Self-efficacy(Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).)
- Psychological Flexibility and Inflexibility Processes(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).)
- Satisfaction with treatment(Post-treatment (T3; 8 weeks after T1).)
- Adherence to treatment(From the moment the treatment app is downloaded (T1), to the completion of the treatment period (T3). Up to 10 weeks.)
研究者
Rocio de la Vega de Carranza, PhD
"Ramón y Cajal" Researcher; Principal Investigator
University of Malaga