Chronic PainEDEANCT06060431
Effectiveness of a Pain Science Education Programme in Adolescent Students.
A study testing Pain Science Education in people with Chronic Pain and Pain, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
The aim of this study is to analyze the effectiveness of a Pain Science Education program to improve the conceptualization of pain in adolescents between 11 and 13 years old, schooled in the first year of Compulsory Secondary Education. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Pain, Pediatric ALL
- What is being tested?
- Pain Science Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2021to 1 Mar 2024
- 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 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- to be schooled at the El Cim school
- to be between 10 and 16 years old (both included)
- to have or have had pain in the last month; to be able to read and write in Catalan and/or Spanish.
Who cannot join
- had an intellectual disability and/or cognitive impairment that interfered with their participation
- had not submitted the informed consent form duly completed and signed by their legal guardians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Specific Pain Science Education Programme in Adolescent Students. Randomised Controlled Clinical Trial.
The aim of this study is to analyze the effectiveness of a Pain Science Education program to improve the conceptualization of pain in adolescents between 11 and 13 years old, schooled in the first year of Compulsory Secondary Education.
Read the detailed description
Design:
Randomized controlled clinical trial. The primary endpoint of the study was pain conceptualization recorded by a questionnaire.
Setting:
The participants were school-age children attending a different high school in the province of Barcelona.
Participants:
Of the 450 potential school participants, 306 agreed to participate. 13 pupils were excluded when applying the eligibility criteria, so the resulting sample was of 293
- Conditions
- Chronic Pain, Pain, Pediatric ALL
- Being tested
- Pain Science Education
- Medical subject headings
- Chronic Pain, Pain, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Science EducationOther
The Pain Science Education program consists of two workshops, 90 and 60 minutes in length, one week apart. The content of the workshops aims to provide students with information about the contemporary pain paradigm and to re-conceptualize pain.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will carry out the sessions of the specific Pain Sciences program. This intervention is based on two educational sessions of 90 and 60 minutes each, separated by one week. Receives: Other: Pain Science Education |
| Control Group | No intervention | The control group will not perform any specific intervention and will follow their usual academic curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conceptualization of Pain Questionnaire (COPAQ)
The Conceptualization of Pain Questionnaire (COPAQ) consist of 15 items and asks respondents to respond if they believe the items/statements to be true or false, although they are allowed to respond undecided. A score of 0 is given to incorrect responses and those marked as undecided; the sum of all the correct answers gives the total score. The higher the score, the better the participant understands the concept of pain.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Dec 2021
- Primary completion30 Sep 2022
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Menés Fernández, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060431
- Sponsor's protocol ID
- 02/2022
- Acronym
- EDEA
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pate JW, Noblet T, Hush JM, Hancock MJ, Sandells R, Pounder M, Pacey V. Exploring the concept of pain of Australian children with and without pain: qualitative study. BMJ Open. 2019 Oct 28;9(10):e033199. doi: 10.1136/bmjopen-2019-033199.
PubMed 31662406Mankelow J, Ravindran D, Graham A, Suri S, Pate JW, Ryan CG, Martin D. An evaluation of a one-day pain science education event in a high school setting targeting pain related beliefs, knowledge, and behavioural intentions. Musculoskelet Sci Pract. 2023 Aug;66:102818. doi: 10.1016/j.msksp.2023.102818. Epub 2023 Jun 27.
PubMed 37418949Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. doi: 10.1016/j.jpain.2007.10.015. Epub 2007 Dec 21.
PubMed 18088558Menes Fernandez L, Salvat I, Adillon C. Effectiveness of a pain science education programme in middle school students: a randomised controlled trial. Front Public Health. 2025 Jan 22;12:1423716. doi: 10.3389/fpubh.2024.1423716. eCollection 2024.
PubMed 39911778
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Specific Pain Science Education Programme in Adolescent Students. Randomised Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06060431
- Acronym / sponsor ID
- EDEA / 02/2022
- Conditions
- Chronic Pain, Pain, Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 293 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 29 Sep 2023 (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.
The aim of this study is to analyze the effectiveness of a Pain Science Education program to improve the conceptualization of pain in adolescents between 11 and 13 years old, schooled in the first year of Compulsory Secondary Education.
Detailed description
Design:
Randomized controlled clinical trial. The primary endpoint of the study was pain conceptualization recorded by a questionnaire.
Setting:
The participants were school-age children attending a different high school in the province of Barcelona.
Participants:
Of the 450 potential school participants, 306 agreed to participate. 13 pupils were excluded when applying the eligibility criteria, so the resulting sample was of 293
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Pain Science EducationThe experimental group will carry out the sessions of the specific Pain Sciences program. This intervention is based on two educational sessions of 90 and 60 minutes each, separated by one week. |
| Control Group | No intervention | –The control group will not perform any specific intervention and will follow their usual academic curriculum. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- to be schooled at the El Cim school
- to be between 10 and 16 years old (both included)
- to have or have had pain in the last month; to be able to read and write in Catalan and/or Spanish.
Key exclusion criteria (2 listed)
- had an intellectual disability and/or cognitive impairment that interfered with their participation
- had not submitted the informed consent form duly completed and signed by their legal guardians
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 |
|---|---|---|
| Pain Science EducationThe Pain Science Education program consists of two workshops, 90 and 60 minutes in length, one week apart. The content of the workshops aims to provide students with information about the contemporary pain paradigm and to re-conceptualize pain. | Other | Experimental group |
Primary outcome
Conceptualization of Pain Questionnaire (COPAQ)
Time frame: 1 year
The Conceptualization of Pain Questionnaire (COPAQ) consist of 15 items and asks respondents to respond if they believe the items/statements to be true or false, although they are allowed to respond undecided. A score of 0 is given to incorrect responses and those marked as undecided; the sum of all the correct answers gives the total score. The higher the score, the better the participant understands the concept of pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 31662406Pate JW, Noblet T, Hush JM, Hancock MJ, Sandells R, Pounder M, Pacey V. Exploring the concept of pain of Australian children with and without pain: qualitative study. BMJ Open. 2019 Oct 28;9(10):e033199. doi: 10.1136/bmjopen-2019-033199.
- Background: PubMed 37418949Mankelow J, Ravindran D, Graham A, Suri S, Pate JW, Ryan CG, Martin D. An evaluation of a one-day pain science education event in a high school setting targeting pain related beliefs, knowledge, and behavioural intentions. Musculoskelet Sci Pract. 2023 Aug;66:102818. doi: 10.1016/j.msksp.2023.102818. Epub 2023 Jun 27.
- Background: PubMed 18088558Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. doi: 10.1016/j.jpain.2007.10.015. Epub 2007 Dec 21.
- Derived from this study: PubMed 39911778Menes Fernandez L, Salvat I, Adillon C. Effectiveness of a pain science education programme in middle school students: a randomised controlled trial. Front Public Health. 2025 Jan 22;12:1423716. doi: 10.3389/fpubh.2024.1423716. eCollection 2024.
- 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 Pain Science Education in people with Chronic Pain and Pain, run by University Rovira i Virgili at 1 site in Spain.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. 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 Spain. 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?
Results are not available in the source record.
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?
Conceptualization of Pain Questionnaire (COPAQ) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06060431, which also lists 4 linked publications.
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 29 Sep 2023.