NCT06664606

Brief Summary

This observational study evaluates the impact of a Pain Neuroscience Education (PNE) program on primary school students in Extremadura, Spain. The study examines satisfaction levels and knowledge acquisition regarding pain neuroscience among students with and without intellectual disabilities. Conducted across both rural and urban educational centers, as well as special and regular education schools, this study aims to identify the effectiveness of PNE in enhancing pain-related knowledge and addressing Sustainable Development Goals (SDGs) awareness. Additionally, the program includes interactive educational activities tailored for accessibility, using resources such as easy-to-read questionnaires and hands-on models, to support inclusive health education. Data collection involves pre- and post-intervention questionnaires to assess satisfaction and knowledge gains, with statistical analysis exploring differences between demographic and school-type groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
413

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
Last Updated

November 8, 2024

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

October 28, 2024

Last Update Submit

November 7, 2024

Conditions

Keywords

Pain ManagementHealth EducationStudentsNeuroscience

Outcome Measures

Primary Outcomes (1)

  • Satisfaction Level and Knowledge Acquisition in Pain Neuroscience Education

    This study measures the level of satisfaction and the knowledge acquired by primary school students with and without intellectual disabilities following participation in a Pain Neuroscience Education (PNE) program. Satisfaction and knowledge are assessed through a structured questionnaire, focusing on three main dimensions: training activity, teacher's role, and understanding of Sustainable Development Goals (SDGs) related to health. The responses are analyzed to evaluate the program's impact across different educational settings, including rural vs. urban and special vs. regular education

    Immediately after completion of the educational intervention

Study Arms (4)

Students in Rural Public Schools

This group consists of primary school students from rural public schools in Extremadura, Spain, participating in a Pain Neuroscience Education (PNE) program.

Behavioral: Pain Neuroscience Education Program (PNE)

Students in Urban Public Schools

This group includes primary school students from urban public schools in Extremadura, Spain, who participated in a Pain Neuroscience Education (PNE) program.

Behavioral: Pain Neuroscience Education Program (PNE)

Students in Special Education Schools

This group consists of students from special education schools in Extremadura, Spain, who have intellectual disabilities. These students participated in the Pain Neuroscience Education (PNE) program, with the goal of understanding program effectiveness in an inclusive educational environment tailored to students with intellectual disabilities.

Behavioral: Pain Neuroscience Education Program (PNE)

Students in Regular Education Schools

This cohort includes primary school students from regular education schools in Extremadura, Spain, without intellectual disabilities. These students participated in the Pain Neuroscience Education (PNE) program, providing insights into the program's impact on general education settings and comparing outcomes with other cohorts.

Behavioral: Pain Neuroscience Education Program (PNE)

Interventions

The Pain Neuroscience Education (PNE) Program is a structured educational intervention aimed at primary school students with and without intellectual disabilities. This program introduces students to basic concepts of pain neuroscience, designed to increase understanding of pain mechanisms and promote healthy pain coping strategies. The intervention was adapted to 'easy reading' format to ensure accessibility for students with intellectual disabilities, and was delivered in both rural and urban school settings in Extremadura, Spain.

Students in Regular Education SchoolsStudents in Rural Public SchoolsStudents in Special Education SchoolsStudents in Urban Public Schools

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of fifth and sixth grade primary school students enrolled in the Autonomous Community of Extremadura, Spain. The participants include students from both regular and special education schools, encompassing both urban and rural areas. The sample represents a diverse group with variations in intellectual abilities, aiming to assess the impact of a neuroscience education program on understanding pain and promoting health knowledge.

You may qualify if:

  • Students enrolled in the fifth or sixth grade of primary education in schools within the Autonomous Community of Extremadura.
  • Students who regularly attend academic activities and complete the educational intervention.

You may not qualify if:

  • Students who do not attend school regularly or who are not expected to complete the intervention.
  • Students with severe cognitive or behavioral impairments that may interfere with participation in the educational activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Extremadura

Badajoz, Badajoz, 06006, Spain

Location

MeSH Terms

Conditions

Chronic PainAgnosiaHealth Education

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Luis Espejo-Antúnez, Ph.D.

    University of Extremadura

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 29, 2024

Study Start

October 1, 2023

Primary Completion

May 31, 2024

Study Completion

June 15, 2024

Last Updated

November 8, 2024

Record last verified: 2023-10

Locations