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

Not Applicable

• Conditions: Chronic Pain
• Interventions: Behavioral: Video-based Motivational Interview combined with Self-Management techniques; Behavioral: In-person Motivational Interview combined with Self-Management techniques

• Registration Number: NCT05220384
• Lead Sponsor: Semmelweis University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Study Start: 2022-02-11
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-14
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Generalized, Video-based therapy	Video-based Motivational Interview combined with Self-Management techniques	-
Personalized In-person therapy	In-person Motivational Interview combined with Self-Management techniques	-

Primary Outcome Measures

Name	Time	Method
Child Self-Efficacy Scale	3 months	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

Name	Time	Method
Visual Analog Scale	3 months	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	3 months	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	3 months	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	3 months	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	3 months	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.

Trial Locations

Locations (1)

Semmelweis University, Health Services Management Training Centre; 🇭🇺 Budapest, Pest State, Hungary