- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03551977
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Kristiansand, Norvège, 4633
- Erik Grasaas
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Attrition rate
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Physical activity
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kristin Haraldstad, PhD, UiA
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 1310 63221
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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