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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Spain
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
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.
Behavioral: Pain Neuroscience Education Program (PNE)
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.
Behavioral: Pain Neuroscience Education Program (PNE)
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.
Behavioral: Pain Neuroscience Education Program (PNE)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Extremadura

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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