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Motivational, Movement and Self-Management Training for Adolescents in Pain (M3 Training)

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
In-person Motivational Interview combined with Self-Management techniques
Video-based Motivational Interview combined with Self-Management techniques
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, self-management, adolescent, motivation

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Semmelweis University, Health Services Management Training CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Personalized In-person therapy

Generalized, Video-based therapy

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Visual Analog Scale
Pain Intensity cores were anchored at 0="no pain" to 100="unbearable pain", with higher scores reflecting greater pain intensity.
Revised Children's Anxiety and Depression Scale
Depression, Anxiety The Revised Child Anxiety and Depression Scale (RCADS) is a 47-item, youth self-report questionnaire with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Additionally, The Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P) similarly assesses parent report of youth's symptoms of anxiety and depression across the same six subscales.
State-Trait Anxiety Inventory for Children
Anxiety The STAI-CH is the definitive instrument for measuring anxiety in children. Based on the same theory as the STAI, the State-Trait Anxiety Inventory for Children (STAI-CH) distinguishes between a general proneness to anxious behavior rooted in the personality and anxiety as a fleeting emotional state. The instrument is designed to be used with upper elementary or junior high school aged children and consists of two twenty-item scales. The measure is easy to read and can be administered verbally to younger children.
Paediatric Pain Disability Index
Disability Each of the 7 items is rated on a scale from 0 to 10 where 0 means no disability and 10 means total disability. PDI results range from 0 to 70 where the higher the score, the greater the degree of disability and impact on life activities due to pain. The PDI is used for initial evaluations and for monitoring pain relief effectiveness and response to other interventions.
Pain Stages of Change Questionnaire for Adolescents and for Parents
Readiness to change The 30-item PSOCQ-A and -P measures include parallel items rated on a 5-point scale: 1="Strongly Disagree", 2="Disagree", 3="Undecided or Unsure", 4="Agree", 5="Strongly Agree". Greater readiness to change was conceptualized as lower Precontemplation and/or higher Action/Maintenance scores, while less readiness to change was represented by higher Precontemplation and/or lower Action/Maintenance scores.

Full Information

First Posted
January 21, 2022
Last Updated
December 12, 2022
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT05220384
Brief Title
Motivational, Movement and Self-Management Training for Adolescents in Pain
Acronym
M3 Training
Official Title
Motivational, Movement and Self-Management Training for Hungarian Adolescents Living With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, self-management, adolescent, motivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized In-person therapy
Arm Type
Other
Arm Title
Generalized, Video-based therapy
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
In-person Motivational Interview combined with Self-Management techniques
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Video-based Motivational Interview combined with Self-Management techniques
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child Self-Efficacy Scale
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
Pain Intensity cores were anchored at 0="no pain" to 100="unbearable pain", with higher scores reflecting greater pain intensity.
Time Frame
3 months
Title
Revised Children's Anxiety and Depression Scale
Description
Depression, Anxiety The Revised Child Anxiety and Depression Scale (RCADS) is a 47-item, youth self-report questionnaire with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Additionally, The Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P) similarly assesses parent report of youth's symptoms of anxiety and depression across the same six subscales.
Time Frame
3 months
Title
State-Trait Anxiety Inventory for Children
Description
Anxiety The STAI-CH is the definitive instrument for measuring anxiety in children. Based on the same theory as the STAI, the State-Trait Anxiety Inventory for Children (STAI-CH) distinguishes between a general proneness to anxious behavior rooted in the personality and anxiety as a fleeting emotional state. The instrument is designed to be used with upper elementary or junior high school aged children and consists of two twenty-item scales. The measure is easy to read and can be administered verbally to younger children.
Time Frame
3 months
Title
Paediatric Pain Disability Index
Description
Disability Each of the 7 items is rated on a scale from 0 to 10 where 0 means no disability and 10 means total disability. PDI results range from 0 to 70 where the higher the score, the greater the degree of disability and impact on life activities due to pain. The PDI is used for initial evaluations and for monitoring pain relief effectiveness and response to other interventions.
Time Frame
3 months
Title
Pain Stages of Change Questionnaire for Adolescents and for Parents
Description
Readiness to change The 30-item PSOCQ-A and -P measures include parallel items rated on a 5-point scale: 1="Strongly Disagree", 2="Disagree", 3="Undecided or Unsure", 4="Agree", 5="Strongly Agree". Greater readiness to change was conceptualized as lower Precontemplation and/or higher Action/Maintenance scores, while less readiness to change was represented by higher Precontemplation and/or lower Action/Maintenance scores.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Szilvia Ádám, PhD
Phone
+36 70 271 7214
Email
adam.szilvia@emk.semmelweis.hu
Facility Information:
Facility Name
Semmelweis University, Health Services Management Training Centre
City
Budapest
State/Province
Pest State
ZIP/Postal Code
1125
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Szilvia Ádám, PhD
Phone
+36 70 271 7214
Email
adam.szilvia@emk.semmelweis.hu
First Name & Middle Initial & Last Name & Degree
János Major, MD,PhD
First Name & Middle Initial & Last Name & Degree
Katalin Forgács-Kristóf, MSc
First Name & Middle Initial & Last Name & Degree
Szilvia Ádám, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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