Chronic PainM3 TrainingNCT05220384
Motivational, Movement and Self-Management Training for Adolescents in Pain
A study testing In-person Motivational Interview combined with Self-Management techniques and Video-based Motivational Interview combined with Self-Management techniques in people with Chronic Pain, run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- In-person Motivational Interview combined with Self-Management techniques and Video-based Motivational Interview combined with Self-Management techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteHungary
- Study dates
- 11 Feb 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Health Services Management Training Centre
Budapest, Pest State, 1125
About this study
Official title: Motivational, Movement and Self-Management Training for Hungarian Adolescents Living With Chronic Pain
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
- Being tested
- In-person Motivational Interview combined with Self-Management techniques, Video-based Motivational Interview combined with Self-Management techniques
- Keywords
- chronic pain, self-management, adolescent, motivation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person Motivational Interview combined with Self-Management techniquesBehavioural
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.
Video-based Motivational Interview combined with Self-Management techniquesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized In-person therapy | Other | Not described Receives: Behavioral: In-person Motivational Interview combined with Self-Management techniques |
| Generalized, Video-based therapy | Other | Not described Receives: Behavioral: Video-based Motivational Interview combined with Self-Management techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (5)
Visual Analog Scale
Pain Intensity cores were anchored at 0="no pain" to 100="unbearable pain", with higher scores reflecting greater pain intensity.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start11 Feb 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220384
- Sponsor's protocol ID
- IV/7741-3/2021/EKU
- Acronym
- M3 Training
- Status last verified
- Apr 2023
- First submitted
- 21 Jan 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational, Movement and Self-Management Training for Hungarian Adolescents Living With Chronic Pain
- ClinicalTrials.gov ID
- NCT05220384
- Acronym / sponsor ID
- M3 Training / IV/7741-3/2021/EKU
- Conditions
- Chronic Pain
- Keywords
- chronic pain, self-management, adolescent, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person Motivational Interview combined with Self-Management techniquesThis 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. | Behavioural | Personalized In-person therapy |
| Video-based Motivational Interview combined with Self-Management techniquesThis 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. | Behavioural | Generalized, Video-based therapy |
Primary outcome
Child Self-Efficacy Scale
Time frame: 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).
5 secondary outcomes
Visual Analog Scale
Time frame: 3 months
Revised Children's Anxiety and Depression Scale
Time frame: 3 months
State-Trait Anxiety Inventory for Children
Time frame: 3 months
Paediatric Pain Disability Index
Time frame: 3 months
Pain Stages of Change Questionnaire for Adolescents and for Parents
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person Motivational Interview combined with Self-Management techniques and Video-based Motivational Interview combined with Self-Management techniques in people with Chronic Pain, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Self-Efficacy Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.