Clinical trial NCT05731401: Expressed Beliefs About the Cause of Pain in a Paediatric Population
Official title: Expressed Beliefs About the Cause of Pain in a Paediatric Population: a Mixed Explanatory Sequential Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Pediatric ALL
Pain Perception
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 345
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Explanations of the cause of pain
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vilanova i la Geltrú
country: Spain
facility: Laura Menés Fernández
state: Barcelona
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.