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Effectiveness of a Pain Science Education Programme in Adolescent Students. (EDEA)

Primary Purpose

Chronic Pain, Pain, Pediatric ALL

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pain Science Education
Sponsored by
University Rovira i Virgili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Pain

Eligibility Criteria

11 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Laura Menés Fernández

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control Group

Arm Description

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.

The control group will not perform any specific intervention and will follow their usual academic curriculum.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2023
Last Updated
September 23, 2023
Sponsor
University Rovira i Virgili
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1. Study Identification

Unique Protocol Identification Number
NCT06060431
Brief Title
Effectiveness of a Pain Science Education Programme in Adolescent Students.
Acronym
EDEA
Official Title
Effectiveness of a Specific Pain Science Education Programme in Adolescent Students. Randomised Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Rovira i Virgili

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Pain, Pediatric ALL

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will not perform any specific intervention and will follow their usual academic curriculum.
Intervention Type
Other
Intervention Name(s)
Pain Science Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Conceptualization of Pain Questionnaire (COPAQ)
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Laura Menés Fernández
City
Vilanova i la Geltrú
State/Province
Barcelona
ZIP/Postal Code
08800
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31662406
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.
Results Reference
background
PubMed Identifier
37418949
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.
Results Reference
background
PubMed Identifier
18088558
Citation
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.
Results Reference
background

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Effectiveness of a Pain Science Education Programme in Adolescent Students.

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