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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06114927
Other study ID # Ceim: 114/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date June 30, 2023

Study information

Verified date November 2023
Source University Rovira i Virgili
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 324
Est. completion date June 30, 2023
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Rovira i Virgili University Tarragona

Sponsors (1)

Lead Sponsor Collaborator
University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Conceptualization of Pain Questionnaire (COPAQ-S) Spanish version. 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 Age Years 1 year
Secondary Gender Female, male 1 year
Secondary School Year Years 1 year
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