Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
112 participants
INTERVENTIONAL
2017-11-28
2018-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Behavioral Medicine Treatment for Adolescents in Pain
NCT01381263
Opp - a Universal Mental Health Promoting Mobile Application for Adolescents
NCT05211713
Mind Power - A CBT Based Program for Adolescents
NCT03647826
Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents
NCT03287622
Adjustment of Adopted Adolescents in Their Families
NCT03872895
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
iCanCope with Pain
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.
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.
iCanCope with Pain control
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
iCanCope with Pain
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.
iCanCope with Pain control
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. with persistent and/or chronic pain, weekly suffered and lasting 3 months or more based on subjective reporting
3. be able to read and understand Norwegian
4. have their own smartphone.
Exclusion Criteria
2. Adolescents that have participated in the usability testing of the Norwegian iCanCope with Pain app
3. 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.
16 Years
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Hospital for Sick Children
OTHER
University of Agder
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Erik Grasaas
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kristin Haraldstad, PhD
Role: PRINCIPAL_INVESTIGATOR
UiA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Erik Grasaas
Kristiansand, , Norway
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1310 63221
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.