Motivational, Movement and Self-Management Training for Adolescents in Pain

NCT05220384 | Completed

• 1 other identifier: IV/7741-3/2021/EKU
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

With this randomized controlled trial, we have three aims. First of all, to investigate underlying mechanisms that might contribute to the success of a physical activity focused self-management program in paediatric chronic pain. Second of all, to determine the minimum intervention needed for improving physical activity amongst adolescents who live with chronic pain. For this we are comparing an in-person and a video-based motivational interviewing training combined with self-management techniques. Third of all, to investigate the mediating effect of autonomy in adolescents with chronic pain.

Conditions

Chronic Pain

Keywords

chronic pain; self-management; adolescent; motivation

Outcome Measures

Primary Outcomes (1)

• Child Self-Efficacy Scale

  The Pain Self-efficacy Scale is a 7item measure assessing child self-efficacy for functioning normally when in pain (PSES-C, PSES-P; Bursch et al., 2006). An example item is "How sure are you that you can take care of yourself when you have pain?" Items are scored on a 5-point Likert scale with lower scores indicating higher self-efficacy. Initial validation provided support for the measure's validity and reliability, and internal consistency in this sample was strong (a ¼ .90).

  3 months

Secondary Outcomes (5)

• Visual Analog Scale

  3 months

• Revised Children's Anxiety and Depression Scale

  3 months

• State-Trait Anxiety Inventory for Children

  3 months

• Paediatric Pain Disability Index

  3 months

• Pain Stages of Change Questionnaire for Adolescents and for Parents

  3 months

Study Arms (2)

Personalized In-person therapy

OTHER

Behavioral: In-person Motivational Interview combined with Self-Management techniques

Generalized, Video-based therapy

OTHER

Behavioral: Video-based Motivational Interview combined with Self-Management techniques

Interventions

In-person Motivational Interview combined with Self-Management techniques BEHAVIORAL

This is an approximately 30 mins in-person, semi-structured, semi-personalized physical activity focused Motivational Interviewing treatment with self-management techniques. (This therapy is an add on to the "usual therapy" that is given to the adolescents who present at the hospital.) During the interactive treatment a self-management workbook will be filled out by the adolescent for the purpose of further data collection. This in-person therapy at the hospital is followed by two booster sessions via phone at the 1st week post meeting date and 1 month post meeting date.

Personalized In-person therapy

Video-based Motivational Interview combined with Self-Management techniques BEHAVIORAL

This is a series of three videos comprising a structured activity focused Motivational Interviewing treatment with self-management techniques. The videos' thematic follow the semi-structured interview elements to ensure that it is a true sham of the in-person one. (This therapy is an add on to the "usual therapy" that is given to the adolescents who present at the hospital.) This first video is going to be watched by adolescents at the hospital. During the interactive video-treatment a self-management workbook will be filled out by the adolescent for the purpose of further data collection. The second video is going to be sent to the participants via e-mail on the 1st week post meeting date and the third video is on the 1-month post meeting date.

Generalized, Video-based therapy

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 12-18 years
• Experiencing pain at least 3 months
• Good reading, writing and listening skills in Hungarian language
• Self-sufficient
• Access to internet and phone
• No active cancer.

You may not qualify if:

• Age is not between 12-18 years
• Experiencing pain less then 3 months
• Not able to read, write and listen in Hungarian
• Not self-sufficient
• No access to internet and phone
• Active cancer.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University, Health Services Management Training Centre

Budapest, Pest State, 1125, Hungary

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: February 11, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 28, 2026

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)