Expressed Beliefs About the Cause of Pain in a Paediatric Population (EBPain)

February 7, 2023 updated by: Laura Menés Fernández, University Rovira i Virgili

Expressed Beliefs About the Cause of Pain in a Paediatric Population: a Mixed Explanatory Sequential Study.

The aims of this study are to explore what beliefs children and adolescents manifest about the cause of the pain they describe; to compare whether if there are differences between beliefs by age and by persistence of pain; and to relate explanations of the cause of pain with current scientific evidence to determine if these beliefs are erroneous.

Study Overview

Status

Completed

Detailed Description

Design:

Mixed (explanatory sequential). The primary endpoint of the study were explanations of the cause of pain recorded by means of an open-ended question.

Setting:

The participants were school-age children attending a charted school in the province of Barcelona.

Participants:

Of the 345 potential school participants, 306 agreed to participate. 36 pupils were excluded when applying the eligibility criteria, so the resulting sample was of 270.

Study Type

Observational

Enrollment (Actual)

345

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

    • 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

10 years to 16 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participants in this study were a convenience sample of schoolchildren aged 10- 16 years from a charter school (Barcelona, Spain), a school large enough to have a sufficient sample.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explanations of the cause of pain
Time Frame: 1 year

Participants were asked to fill out a questionnaire where they were asked "Do you have or have you had pain in the last month?" and "Why do you think you have or have had this pain?".

The answer is an open response.

1 year

Collaborators and Investigators

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

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.

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)

September 1, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114/2018

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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