The Norwegian "iCanCope With Pain" App

NCT03551977 | Completed

• 1 other identifier: 1310 63221
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• Attrition rate

  Change in participants completed the post-questionnaire divided by the number of participants at baseline.

  Baseline and 8-weeks

• App engagement

  Completion of daily symptom check-ins was used as a proxy for app engagement.

  Baseline to 8 weeks.

Secondary Outcomes (10)

• Physical activity

  Baseline and 8 weeks (post-intervention)

• Coping

  Baseline and 8 weeks (post-intervention)

• Social participation

  Baseline and 8 weeks (post-intervention)

• Over-The-Counter (OTC) analgesics

  Baseline and 8 weeks (post-intervention)

• Perceived social support from friends

  Baseline and 8 weeks (post-intervention)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: iCanCope with Pain

Control group

ACTIVE COMPARATOR

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.

Behavioral: iCanCope with Pain control

Interventions

iCanCope with Pain BEHAVIORAL

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.

Intervention group

iCanCope with Pain control BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Agder: lead
• The Hospital for Sick Children: collaborator

Study Sites (1)

Erik Grasaas

Kristiansand, 4633, Norway

Location

Related Publications (2)

• 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.

  PMID: 35897086 DERIVED

• 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.

  PMID: 32000787 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Kristin Haraldstad, PhD

  UiA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single-centre, RCT study design with two arms, one control group (N=56) and one intervention group (N=56).

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 11, 2018
• Study Start: November 28, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)