Effectiveness of a Pain Science Education Programme in Adolescent Students.

Pain Clinical Trial

— EDEA  

Official title:

Effectiveness of a Specific Pain Science Education Programme in Adolescent Students. Randomised Controlled Clinical Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06060431
• Other study ID #: 02/2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: September 2023
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 293
• Est. completion date: March 1, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 13 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Pain
• Pediatric ALL

Intervention

Other:
• Pain Science Education
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.

Locations

Country	Name	City	State
Spain	Laura Menés Fernández	Vilanova i la Geltrú	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Huguet 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. — View Citation

Mankelow 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year