Cultural Adaptation and Evaluation of the "iCanCope With Pain" App Among Norwegian Adolescents Living With Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- App engagement
研究概览
简要总结
Background: Research evidence shows that prevalence of pain in adolescents is increasing and is therefore recognized as a growing health problem. Psychological interventions delivered remotely through the internet may reduce intensity or severity of pain among children and adolescents with chronic pain. The iCanCope with Pain program is an existing web- and mobile-based self-management program, which is developed as a multi-center study funded by the Canadian Institutes of Health Research and is based on identified health care needs and current best practices for pain self-management.
Objectives: The primary objectives are to describe the translation and cultural adaptation of the Norwegian version of the iCanCope with Pain mobile application and evaluate the effect in an upcoming randomized controlled trail with adolescents with chronic pain.
Study sample: 16-19-year-old adolescents with self-declared persistent and/or chronic pain. Recruited from high schools in Southern Norway.
Theoretical framework: Cognitive behavioral therapy (CBT) is explained by an integration of behavioral and cognitive theories of human behavior and psychopathology and is often the preferred treatment of choice for adolescents with different health disorders. The theoretical framework of CBT is integrated in the iCanCope with Pain app in terms of five components. The intervention group will receive the app with all five components: (I) symptom trackers for pain, sleep, mood, physical, and social function; (II) goal setting to improve pain and function; (III) coping toolbox of pain self-management strategies; (IV) social support; (V) age-appropriate pain education. The control group will receive the app with only the first self-registration component (I) symptom trackers for pain, sleep, mood, physical, and social function.
Methods: Both qualitative and quantitative data will be gathered for evaluating the Norwegian version of the iCanCope with Pain app. Usability testing are assessed in both laboratory settings and in field using observation, interviews and questionnaires, which provide necessary information for an upcoming randomized controlled trail (RCT). Outcomes will in the RCT be measured at baseline (mid-April) and after an 8 weeks intervention (mid-June).
The study is part of a PhD project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16-19-year-old adolescents
- •with persistent and/or chronic pain, weekly suffered and lasting 3 months or more based on subjective reporting
- •be able to read and understand Norwegian
- •have their own smartphone.
排除标准
- •Adolescents with cognitive disability or diseases, because of the risk of not correctly understanding the iCanCope with Pain program via self-report, goal setting and/or library reading.
- •Adolescents that have participated in the usability testing of the Norwegian iCanCope with Pain app
- •Adolescents with diagnoses from a pathological or medical origin (e.g hematology/oncology patients) will also be excluded because the program was not specifically designed for these pain groups.
研究组 & 干预措施
Intervention group
The intervention group will receive the iCanCope with Pain app with all five components: (I) symptom trackers for pain, sleep, mood, physical, and social function; (II) goal setting to improve pain and function; (III) coping toolbox of pain self-management strategies; (IV) social support; (V) age-appropriate pain education
干预措施: iCanCope with Pain (Behavioral)
Control group
The control group will receive the iCanCope with Pain control app with only the first self-registration component (I) symptom trackers for pain, sleep, mood, physical, and social function.
干预措施: iCanCope with Pain control (Behavioral)
结局指标
主要结局
App engagement
时间窗: Baseline to 8 weeks.
Completion of daily symptom check-ins was used as a proxy for app engagement.
Attrition rate
时间窗: Baseline and 8-weeks
Change in participants completed the post-questionnaire divided by the number of participants at baseline.
次要结局
- Pain experience(Baseline and 8 weeks (post-intervention))
- Physical activity(Baseline and 8 weeks (post-intervention))
- Coping(Baseline and 8 weeks (post-intervention))
- Health-related quality of life (HRQOL)(Baseline and 8 weeks (post-intervention))
- Pain self-efficacy questionnaire(Baseline and 8 weeks (post-intervention))
- Social participation(Baseline and 8 weeks (post-intervention))
- Over-The-Counter (OTC) analgesics(Baseline and 8 weeks (post-intervention))
- Perceived social support from friends(Baseline and 8 weeks (post-intervention))
- Anxiety and depression(Baseline and 8 weeks (post-intervention))
- Global impression of change(After 8 weeks (post-intervention))
研究者
Erik Grasaas
Principal Investigator
University of Agder