- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05731401
Expressed Beliefs About the Cause of Pain in a Paediatric Population (EBPain)
Expressed Beliefs About the Cause of Pain in a Paediatric Population: a Mixed Explanatory Sequential Study.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Barcelona
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Vilanova i la Geltrú, Barcelona, Spain, 08800
- Laura Menés Fernández
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Publications and helpful links
General Publications
- Huguet 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.
- 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.
- Salvat 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.
- Hassett 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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