- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Kristiansand, Norge, 4633
- Erik Grasaas
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
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.
|
Aktiv komparator: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Attrition rate
Tidsram: Baseline and 8-weeks
|
Change in participants completed the post-questionnaire divided by the number of participants at baseline.
|
Baseline and 8-weeks
|
App engagement
Tidsram: Baseline to 8 weeks.
|
Completion of daily symptom check-ins was used as a proxy for app engagement.
|
Baseline to 8 weeks.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Physical activity
Tidsram: Baseline and 8 weeks (post-intervention)
|
Change in total score of the International Physical Activity Questionnaire (IPAQ).
Higher values at post-intervention represent a better outcome.
|
Baseline and 8 weeks (post-intervention)
|
Coping
Tidsram: Baseline and 8 weeks (post-intervention)
|
Change in total score of the General Self-Efficacy Questionnaire Short Version (GSEQ).
Higher values at post-intervention represent a better outcome.
|
Baseline and 8 weeks (post-intervention)
|
Social participation
Tidsram: Baseline and 8 weeks (post-intervention)
|
Change in total score of school absence (General Information Questionnaire).
Lower values at post-intervention represent a better outcome.
|
Baseline and 8 weeks (post-intervention)
|
Over-The-Counter (OTC) analgesics
Tidsram: Baseline and 8 weeks (post-intervention)
|
Change in total score of OTC analgesics consumption (General Information Questionnaire).
Lower values at post-intervention represent a better outcome.
|
Baseline and 8 weeks (post-intervention)
|
Perceived social support from friends
Tidsram: Baseline and 8 weeks (post-intervention)
|
Change in total score of the Perceived Social Support from friends Questionnaire (PSS).
Higher values at post-intervention represent a better outcome.
|
Baseline and 8 weeks (post-intervention)
|
Pain self-efficacy questionnaire
Tidsram: Baseline and 8 weeks (post-intervention)
|
Change in total score of the Pain Self-Efficacy Questionnaire (PSEQ).
Higher values at post-intervention represent a better outcome.
|
Baseline and 8 weeks (post-intervention)
|
Anxiety and depression
Tidsram: Baseline and 8 weeks (post-intervention)
|
Change in total score of the Hospital Anxiety and Depression Scale Questionnaire (HADS).
Lower values at post-intervention represent a better outcome.
|
Baseline and 8 weeks (post-intervention)
|
Global impression of change
Tidsram: After 8 weeks (post-intervention)
|
Change in Patients' Global Impression of Change Scale (PGIC) from 1-7.
Higher values at post-intervention represent a better outcome.
|
After 8 weeks (post-intervention)
|
Health-related quality of life (HRQOL)
Tidsram: Baseline and 8 weeks (post-intervention)
|
Change in total score of the Kidscreen 52 Questionnaire.
Higher values at post-intervention represent a better outcome.
|
Baseline and 8 weeks (post-intervention)
|
Pain experience
Tidsram: Baseline and 8 weeks (post-intervention)
|
Change in total score of the Lubeck Pain Questionnaire (LPQ).
Lower values at post-intervention represent a better outcome.
|
Baseline and 8 weeks (post-intervention)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kristin Haraldstad, PhD, UiA
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1310 63221
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Smärta
-
Korea University Anam HospitalKorea UniversityAvslutadSmärtmätning | Visual Analog Pain Scale
-
Alanya Alaaddin Keykubat UniversityAvslutadSterilisering, Tubal | Visual Analog Pain Scale
-
Turkish Ministry of Health, Kahramanmaras Provincial...RekryteringVisual Analog Pain ScaleKalkon
-
Ankara UniversityAvslutadSmärtmätning | Visual Analog Pain ScaleKalkon
-
East Carolina UniversityIndragen
-
University Hospital, GrenobleAvslutadDövhet | Visual Analog Pain ScaleFrankrike
-
Moens MaartenRekryteringMisslyckad Ryggkirurgi Syndrom | Persistent Spinal Pain Syndrome Typ 2Belgien
-
Moens MaartenVrije Universiteit BrusselRekryteringRyggmärgsstimulering | Persistent Spinal Pain Syndrome Typ 2Belgien
-
Örebro University, SwedenAvslutadPostoperativ smärtintensitet | Rescue Pain KravSverige
-
Wake Forest University Health SciencesRekryteringPhantom Limb Pain (PLP)Förenta staterna
Kliniska prövningar på iCanCope with Pain
-
Massachusetts General HospitalOkändSmärta | Kronisk smärta | Fysisk aktivitetFörenta staterna
-
UNC Lineberger Comprehensive Cancer CenterAvslutadBröstcancer | Fysisk aktivitet | ÅldrandeFörenta staterna
-
Stanford UniversityAktiv, inte rekryterandeResiliens, psykologisk | Bärbara enheter | Psykologisk välbefinnande | Personligt och professionellt förverkligande | MultiomicsFörenta staterna
-
University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) och andra samarbetspartnersAvslutad
-
Tilburg UniversityRekryteringPostpartum depression | Föräldrastress | Postpartum ångestNederländerna
-
Hasselt UniversityAvslutadMultipel sklerosBelgien
-
The Hospital for Sick ChildrenRekryteringTerapiassocierad cancerKanada
-
Hamilton Health Sciences CorporationMcMaster UniversityRekryteringBröstcancer | Cancer, behandlingsrelaterad | Smärta cancerKanada
-
Universidade Federal de Sao CarlosAvslutad