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The Norwegian "iCanCope With Pain" App

4. november 2022 opdateret af: Erik Grasaas, University of Agder

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

112

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Norge
      • Kristiansand, Norge, 4633
        • Erik Grasaas

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 19 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. 16-19-year-old adolescents
  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:

  1. 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.
  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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Adfærdsmæssigt: 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.
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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Attrition rate
Tidsramme: 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
Tidsramme: Baseline to 8 weeks.
Completion of daily symptom check-ins was used as a proxy for app engagement.
Baseline to 8 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical activity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Agder

Samarbejdspartnere

The Hospital for Sick Children

Efterforskere

  • Ledende efterforsker: Kristin Haraldstad, PhD, UiA

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. november 2017

Primær færdiggørelse (Faktiske)

15. juni 2018

Studieafslutning (Faktiske)

15. juni 2018

Datoer for studieregistrering

Først indsendt

15. maj 2018

Først indsendt, der opfyldte QC-kriterier

28. maj 2018

Først opslået (Faktiske)

11. juni 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2022

Sidst verificeret

1. november 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1310 63221

Plan for individuelle deltagerdata (IPD)

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