Ignite Creation Date:
2024-05-06 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03551977
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2018-05-15
Brief Title:
The Norwegian iCanCope With Pain App
Sponsor:
University of Agder
Organization:
University of Agder
Study Overview
Official Title:
Cultural Adaptation and Evaluation of the iCanCope With Pain App Among Norwegian Adolescents Living With Pain
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None