Validation of the Spanish Version of the Conceptualization of Pain Questionnaire (COPAQ-S)

November 2, 2023 updated by: CRISTINA ADILLÓN, University Rovira i Virgili

The goal of this observational study is to develop a questionnaire to assess a child's concept of pain and to evaluate its psychometric properties in schoolchildren aged 8-17 years. The main question[s] it aims to answer are:

  • Validate to Spanish language the Conceptualization of Pain Questionnaire to assess a child's concept of pain.
  • Conduct an analysis to evaluate its psychometric properties. Participants will respond a questionnaire 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The inclusion criteria were: to be able to read and write in Spanish language and excluded if they suffered from an intellectual disability that, according to the teachers, could interfere with their participation in the study procedures.

The main outcome was: The Conceptualization of Pain Questionnaire - Spanish version.

Study Type

Observational

Enrollment (Actual)

324

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
      • Tarragona, Spain, 43201
        • Rovira i Virgili University

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

Sampling Method

Probability Sample

Study Population

Schoolchildren aged 8-17 years.

Description

Inclusion Criteria:

  • Were able to read and write in Spanish

Exclusion Criteria:

  • If they suffered from an intellectual disability that, according to the teachers, could interfere with their participation in the study procedures.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
To answer a 15-question survey.
Behavioral: Validation of a questionnaire
The Conceptualization of Pain Questionnaire (COPAQ-S) Spanish version 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Conceptualization of Pain Questionnaire (COPAQ-S) Spanish version.
Time Frame: 1 year
It 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: 1 year
Years
1 year
Gender
Time Frame: 1 year
Female, male
1 year
School Year
Time Frame: 1 year
Years
1 year

Collaborators and Investigators

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

Sponsor

University Rovira i Virgili

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)

January 1, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

October 29, 2023

First Submitted That Met QC Criteria

October 29, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ceim: 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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