Chronic PainEBPainNCT05731401
Expressed Beliefs About the Cause of Pain in a Paediatric Population
An observational study of Chronic Pain and Pediatric ALL, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Chronic Pain, Pediatric ALL, Pain Perception
- What is being tested?
- Explanations of the cause of pain
- How many people
- 345 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 30 Jun 2022
- 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 10 to 16 years
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Pediatric ALL, Pain Perception
- Being tested
- Explanations of the cause of pain
- Medical subject headings
- Chronic Pain, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explanations of the cause of painOther
When analyzing the responses to the question "Why do you think you have or have had this pain?" two themes emerged from the data: 'explanations associated with damage', and 'explanations not associated with damage'.
The themes were sub-classified into sub-themes, according to the type of explanation
What is being measured
The primary outcome is the main question the study is designed to answer.
Explanations of the cause of pain
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.
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 posted16 Feb 2023
- Study start1 Sep 2021
- Primary completion1 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Menés Fernández, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731401
- Sponsor's protocol ID
- 114/2018
- Acronym
- EBPain
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pate JW, Noblet T, Hush JM, Hancock MJ, Sandells R, Pounder M, Pacey V. Exploring the concept of pain of Australian children with and without pain: qualitative study. BMJ Open. 2019 Oct 28;9(10):e033199. doi: 10.1136/bmjopen-2019-033199.
PubMed 31662406Salvat I, Adillon C, Andres EM, Monterde S, Miro J. Development of the Conceptualization of Pain Questionnaire: A Measure to Study How Children Conceptualize Pain. Int J Environ Res Public Health. 2021 Apr 6;18(7):3821. doi: 10.3390/ijerph18073821.
PubMed 33917429Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. doi: 10.1016/j.jpain.2007.10.015. Epub 2007 Dec 21.
PubMed 18088558Hassett AL, Hilliard PE, Goesling J, Clauw DJ, Harte SE, Brummett CM. Reports of chronic pain in childhood and adolescence among patients at a tertiary care pain clinic. J Pain. 2013 Nov;14(11):1390-7. doi: 10.1016/j.jpain.2013.06.010. Epub 2013 Sep 7.
PubMed 24021576
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressed Beliefs About the Cause of Pain in a Paediatric Population: a Mixed Explanatory Sequential Study.
- ClinicalTrials.gov ID
- NCT05731401
- Acronym / sponsor ID
- EBPain / 114/2018
- Conditions
- Chronic Pain, Pediatric ALL, Pain Perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Feb 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 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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Explanations of the cause of painWhen analyzing the responses to the question "Why do you think you have or have had this pain?" two themes emerged from the data: 'explanations associated with damage', and 'explanations not associated with damage'. The themes were sub-classified into sub-themes, according to the type of explanation | Other | – |
Primary outcome
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.
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 16 Feb 2023.
- Background: PubMed 31662406Pate JW, Noblet T, Hush JM, Hancock MJ, Sandells R, Pounder M, Pacey V. Exploring the concept of pain of Australian children with and without pain: qualitative study. BMJ Open. 2019 Oct 28;9(10):e033199. doi: 10.1136/bmjopen-2019-033199.
- Background: PubMed 33917429Salvat I, Adillon C, Andres EM, Monterde S, Miro J. Development of the Conceptualization of Pain Questionnaire: A Measure to Study How Children Conceptualize Pain. Int J Environ Res Public Health. 2021 Apr 6;18(7):3821. doi: 10.3390/ijerph18073821.
- Background: PubMed 18088558Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. doi: 10.1016/j.jpain.2007.10.015. Epub 2007 Dec 21.
- Background: PubMed 24021576Hassett AL, Hilliard PE, Goesling J, Clauw DJ, Harte SE, Brummett CM. Reports of chronic pain in childhood and adolescence among patients at a tertiary care pain clinic. J Pain. 2013 Nov;14(11):1390-7. doi: 10.1016/j.jpain.2013.06.010. Epub 2013 Sep 7.
- 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 Chronic Pain and Pediatric ALL, 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 3 inclusion and 2 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 16 Feb 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?
Explanations of the cause of pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05731401, which also lists 4 linked publications.
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 16 Feb 2023.