The Norwegian "iCanCope With Pain" App
Cultural Adaptation and Evaluation of the "iCanCope With Pain" App Among Norwegian Adolescents Living With Pain
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Kristiansand, Norsko, 4633
- Erik Grasaas
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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
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The participants are free to use the Norwegian iCanCope with Pain app as much as they want during the 8 week intervention period.
The only support available is technical support.
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Aktivní komparátor: 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.
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The participants are free to use the Norwegian iCanCope with Pain control app as much as they want during the 8 week intervention period.
The only support available is technical support.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Attrition rate
Časové okno: Baseline and 8-weeks
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Change in participants completed the post-questionnaire divided by the number of participants at baseline.
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Baseline and 8-weeks
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App engagement
Časové okno: Baseline to 8 weeks.
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Completion of daily symptom check-ins was used as a proxy for app engagement.
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Baseline to 8 weeks.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Physical activity
Časové okno: Baseline and 8 weeks (post-intervention)
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Change in total score of the International Physical Activity Questionnaire (IPAQ).
Higher values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Coping
Časové okno: Baseline and 8 weeks (post-intervention)
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Change in total score of the General Self-Efficacy Questionnaire Short Version (GSEQ).
Higher values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Social participation
Časové okno: Baseline and 8 weeks (post-intervention)
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Change in total score of school absence (General Information Questionnaire).
Lower values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Over-The-Counter (OTC) analgesics
Časové okno: Baseline and 8 weeks (post-intervention)
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Change in total score of OTC analgesics consumption (General Information Questionnaire).
Lower values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Perceived social support from friends
Časové okno: Baseline and 8 weeks (post-intervention)
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Change in total score of the Perceived Social Support from friends Questionnaire (PSS).
Higher values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Pain self-efficacy questionnaire
Časové okno: Baseline and 8 weeks (post-intervention)
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Change in total score of the Pain Self-Efficacy Questionnaire (PSEQ).
Higher values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Anxiety and depression
Časové okno: Baseline and 8 weeks (post-intervention)
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Change in total score of the Hospital Anxiety and Depression Scale Questionnaire (HADS).
Lower values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Global impression of change
Časové okno: After 8 weeks (post-intervention)
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Change in Patients' Global Impression of Change Scale (PGIC) from 1-7.
Higher values at post-intervention represent a better outcome.
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After 8 weeks (post-intervention)
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Health-related quality of life (HRQOL)
Časové okno: Baseline and 8 weeks (post-intervention)
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Change in total score of the Kidscreen 52 Questionnaire.
Higher values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Pain experience
Časové okno: Baseline and 8 weeks (post-intervention)
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Change in total score of the Lubeck Pain Questionnaire (LPQ).
Lower values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Kristin Haraldstad, PhD, UiA
Publikace a užitečné odkazy
Obecné publikace
- Grasaas E, Helseth S, Fegran L, Stinson J, Smastuen M, Lalloo C, Haraldstad K. App-based intervention among adolescents with persistent pain: a pilot feasibility randomized controlled trial. Pilot Feasibility Stud. 2022 Jul 27;8(1):158. doi: 10.1186/s40814-022-01113-0.
- Grasaas E, Helseth S, Fegran L, Stinson J, Smastuen M, Haraldstad K. Health-related quality of life in adolescents with persistent pain and the mediating role of self-efficacy: a cross-sectional study. Health Qual Life Outcomes. 2020 Jan 30;18(1):19. doi: 10.1186/s12955-020-1273-z.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 1310 63221
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