NCT06060431

Brief Summary

The aim of this study is to analyze the effectiveness of a Pain Science Education program to improve the conceptualization of pain in adolescents between 11 and 13 years old, schooled in the first year of Compulsory Secondary Education.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
293

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

September 18, 2023

Last Update Submit

September 23, 2023

Conditions

Chronic PainPainPediatric ALL

Outcome Measures

Primary Outcomes (1)

  • Conceptualization of Pain Questionnaire (COPAQ)

    The Conceptualization of Pain Questionnaire (COPAQ) 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.

    1 year

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will carry out the sessions of the specific Pain Sciences program. This intervention is based on two educational sessions of 90 and 60 minutes each, separated by one week.

Other: Pain Science Education

Control Group

NO INTERVENTION

The control group will not perform any specific intervention and will follow their usual academic curriculum.

Interventions

Pain Science EducationOTHER

The Pain Science Education program consists of two workshops, 90 and 60 minutes in length, one week apart. The content of the workshops aims to provide students with information about the contemporary pain paradigm and to re-conceptualize pain.

Experimental group

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura Menés Fernández

Vilanova i la Geltrú, Barcelona, 08800, Spain

Location

Related Publications (3)

  • 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.

    PMID: 31662406BACKGROUND

  • Mankelow J, Ravindran D, Graham A, Suri S, Pate JW, Ryan CG, Martin D. An evaluation of a one-day pain science education event in a high school setting targeting pain related beliefs, knowledge, and behavioural intentions. Musculoskelet Sci Pract. 2023 Aug;66:102818. doi: 10.1016/j.msksp.2023.102818. Epub 2023 Jun 27.

    PMID: 37418949BACKGROUND

  • 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.

    PMID: 18088558BACKGROUND

MeSH Terms

Conditions

Chronic PainPainPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 29, 2023

Study Start

December 1, 2021

Primary Completion

September 30, 2022

Study Completion

March 1, 2024

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)