- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06664606
Impact of a Pain Neuroscience Education Program on Primary Students with and Without Intellectual Disabilities
November 7, 2024 updated by: Carlos Fernández-Morales, Universidad de Extremadura
Satisfaction and Knowledge Acquisition Following a Pain Neuroscience Education Program in Primary Students with and Without Intellectual Disabilities
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
413
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Badajoz, Spain, 06006
- Universidad de Extremadura
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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 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.
|
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 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.
|
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 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction Level and Knowledge Acquisition in Pain Neuroscience Education
Time Frame: Immediately after completion of the educational intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Luis Espejo-Antúnez, Ph.D., University of Extremadura
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Actual)
May 31, 2024
Study Completion (Actual)
June 15, 2024
Study Registration Dates
First Submitted
October 28, 2024
First Submitted That Met QC Criteria
October 28, 2024
First Posted (Actual)
October 29, 2024
Study Record Updates
Last Update Posted (Estimated)
November 8, 2024
Last Update Submitted That Met QC Criteria
November 7, 2024
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
Clinical Trials on Chronic Pain (back / Neck)
-
Massachusetts General HospitalCompletedChronic Low Back Pain | Chronic Neck PainUnited States
-
The University of Hong KongCompletedChronic Low Back Pain | Chronic Neck PainHong Kong
-
Turku University HospitalCompletedChronic Low Back Pain | Chronic Neck Pain
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH); United States...CompletedChronic Low Back Pain | Chronic Neck PainUnited States
-
Istanbul University - CerrahpasaCompletedChronic Neck Pain | Chronic Low-back Pain (cLBP)Turkey
-
RANDUniversity of California, Los AngelesCompletedChronic Low Back Pain | Chronic Neck PainUnited States
-
Washington D.C. Veterans Affairs Medical CenterRecruitingChronic Back Pain | Chronic Pain (back / Neck)United States
-
Fondazione Don Carlo Gnocchi OnlusRecruitingChronic Non-specific Neck Pain | Chronic Non-Specific Low Back PainItaly
-
Icahn School of Medicine at Mount SinaiAlbert Einstein College of Medicine; The Institute for Family Health; Maryland...CompletedChronic Low Back Pain | Chronic Neck Pain | Osteoarthritis PainUnited States
-
Universidad de ExtremaduraCompletedChronic Neck Pain | Heart Rate Variability | Autonomic Nervous System Dysfunction | Chronic Low Back Pain (CLBP)Spain
Clinical Trials on Pain Neuroscience Education Program (PNE)
-
Aveiro UniversityUnknown
-
Evidence In MotionUniversity of Nevada, Las Vegas; Southwest Baptist UniversityNot yet recruitingChronic Pain
-
Ayşe ŞİMŞEKCompletedPain Management | Pain Knowledge | Physiotherapist StudentsTurkey (Türkiye)
-
Ayşe ŞİMŞEKCompletedChronic Non-specific Low Back Pain | Physiotherapist StudentsTurkey (Türkiye)
-
University of UtahCompleted
-
Universidad Miguel Hernandez de ElcheHospital Universitario San Juan de AlicanteCompletedBack Pain Lower Back ChronicSpain
-
Uskudar UniversityCompletedPain Management | Dysmenorrhea (Disorder)Turkey
-
Vrije Universiteit BrusselUniversiteit AntwerpenCompletedIrritable Bowel Syndrome | Abdominal PainBelgium
-
McMaster UniversityBoston University; University of British Columbia; University of MelbourneCompleted
-
University of ValladolidCompletedPain | Long COVIDSpain