Child DevelopmentCOPAQ-SNCT06114927
Validation of the Spanish Version of the Conceptualization of Pain Questionnaire
An observational study of Child Development and Pain, run by University Rovira i Virgili at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Pain, Adolescent Behavior
- What is being tested?
- Validation of a questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 324 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Schoolchildren aged 8-17 years.
Who may be able to join
- Were able to read and write in Spanish
Who cannot join
- If they suffered from an intellectual disability that, according to the teachers, could interfere with their participation in the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Child Development, Pain, Adolescent Behavior
- Being tested
- Validation of a questionnaire
- Keywords
- survey, children, health knowledge, chronic pain, pain education
- Medical subject headings
- Pain, Adolescent Behavior, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of a questionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants | To answer a 15-question survey. Receives: Behavioral: Validation of a questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
Age
Years
Measured: 1 year
Gender
Female, male
Measured: 1 year
School Year
Years
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jan 2022
- Primary completion30 Sep 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CRISTINA ADILLÓN, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114927
- Sponsor's protocol ID
- Ceim: 114/2018
- Acronym
- COPAQ-S
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Spanish Version of the Conceptualization of Pain Questionnaire
- ClinicalTrials.gov ID
- NCT06114927
- Acronym / sponsor ID
- COPAQ-S / Ceim: 114/2018
- Conditions
- Child Development, Pain, Adolescent Behavior
- Keywords
- survey, children, health knowledge, chronic pain, pain education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Behavioral: Validation of a questionnaireTo answer a 15-question survey. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Schoolchildren aged 8-17 years.
Key inclusion criteria (1 listed)
- Were able to read and write in Spanish
Key exclusion criteria (1 listed)
- If they suffered from an intellectual disability that, according to the teachers, could interfere with their participation in the study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation of a questionnaireThe 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. | Behavioural | Participants |
Primary outcome
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.
3 secondary outcomes
Age
Time frame: 1 year
Gender
Time frame: 1 year
School Year
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development and Pain, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Conceptualization of Pain Questionnaire (COPAQ-S) Spanish version. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.