The Norwegian "iCanCope With Pain" App

November 4, 2022 updated by: 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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kristiansand, Norway, 4633
        • Erik Grasaas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attrition rate
Time Frame: 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
Time Frame: Baseline to 8 weeks.
Completion of daily symptom check-ins was used as a proxy for app engagement.
Baseline to 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kristin Haraldstad, PhD, UiA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2017

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 28, 2018

First Posted (Actual)

June 11, 2018

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 1310 63221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on iCanCope with Pain

3
Subscribe