Chronic Pain (back / Neck)NCT06664606
Impact of a Pain Neuroscience Education Program on Primary Students with and Without Intellectual Disabilities
An observational study of Chronic Pain (back / Neck), run by Universidad de Extremadura at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain (back / Neck)
- What is being tested?
- Pain Neuroscience Education Program (PNE)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 413 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Pain (back / Neck)
- Being tested
- Pain Neuroscience Education Program (PNE)
- Keywords
- Pain Management, Health Education, Students, Neuroscience
- Medical subject headings
- Chronic Pain, Agnosia, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience Education Program (PNE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Pain Neuroscience Education Program (PNE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after completion of the educational intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Oct 2023
- Primary completion31 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain (back / Neck)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Fernández-Morales, Universidad de Extremadura
- Investigators
- Luis Espejo-Antúnez, Ph.D., Study director, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664606
- Sponsor's protocol ID
- 06
- Status last verified
- Oct 2023
- First submitted
- 28 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction and Knowledge Acquisition Following a Pain Neuroscience Education Program in Primary Students with and Without Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT06664606
- Acronym / sponsor ID
- 06
- Conditions
- Chronic Pain (back / Neck)
- Keywords
- Pain Management, Health Education, Students, Neuroscience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Students in Rural Public Schools | – | Behavioral: Pain Neuroscience Education Program (PNE)This group consists of primary school students from rural public schools in Extremadura, Spain, participating in a Pain Neuroscience Education (PNE) program. |
| Students in Urban Public Schools | – | Behavioral: Pain Neuroscience Education Program (PNE)This group includes primary school students from urban public schools in Extremadura, Spain, who participated in a Pain Neuroscience Education (PNE) program. |
| Students in Special Education Schools | – | Behavioral: Pain Neuroscience Education Program (PNE)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. |
| Students in Regular Education Schools | – | Behavioral: Pain Neuroscience Education Program (PNE)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. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Students in Regular Education Schools, Students in Rural Public Schools, Students in Special Education Schools, Students in Urban Public Schools |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Espejo-Antúnez, Ph.D. study director
University of Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain (back / Neck), run by Universidad de Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction Level and Knowledge Acquisition in Pain Neuroscience Education (time frame: Immediately after completion of the educational intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.