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

Sponsor
University Rovira i Virgili (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06060431
Collaborator
(none)
293
1
2
27
10.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pain Science Education
N/A

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

Study Type:
Interventional
Actual Enrollment :
293 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effectiveness of a Specific Pain Science Education Programme in Adolescent Students. Randomised Controlled Clinical Trial.
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

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.

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.

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

  1. Conceptualization of Pain Questionnaire (COPAQ) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laura Menés Fernández Vilanova i la Geltrú Barcelona Spain 08800

Sponsors and Collaborators

  • University Rovira i Virgili

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Laura Menés Fernández, Principal Investigator, University Rovira i Virgili
ClinicalTrials.gov Identifier:
NCT06060431
Other Study ID Numbers:
  • 02/2022
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2023