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

September 23, 2023 updated by: Laura Menés Fernández, University Rovira i Virgili

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

293

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Vilanova i la Geltrú, Barcelona, Spain, 08800
        • Laura Menés Fernández

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Rovira i Virgili

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 23, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 23, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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