Expressed Beliefs About the Cause of Pain in a Paediatric Population

Chronic Pain Clinical Trial

— EBPain  

Official title:

Expressed Beliefs About the Cause of Pain in a Paediatric Population: a Mixed Explanatory Sequential Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05731401
• Other study ID #: 114/2018
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2023
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 these beliefs are erroneous.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: June 30, 2022
• Est. primary completion date: June 1, 2022
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain Perception
• Pediatric ALL

Intervention

Other:
• Explanations of the cause of pain
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

Locations

Country	Name	City	State
Spain	Laura Menés Fernández	Vilanova i la Geltrú	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year