Effectiveness of Health Education Program on Musculoskeletal Pain Management in Primary School Students

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-10

Study Completion Date

2025-08-10

Brief Summary

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Musculoskeletal pain during childhood can negatively affect school attendance, physical activity, and social participation. This study will evaluate the effectiveness of the school-based health education program 'SocLaLola', which uses a comic-based narrative to introduce children to pain science concepts and promote healthy lifestyle habits. The intervention will be compared with a standard program focused on sedentary behavior prevention. Students aged 8 to 11 years from two primary schools will participate. The primary objective is to determine whether SocLaLola is more effective than the comparison program in improving children's knowledge about pain and in reducing fear-avoidance beliefs related to physical activity.

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Detailed Description

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This randomized controlled trial will evaluate the effectiveness of the 'SocLaLola' school-based health education program compared with a sedentary lifestyle prevention program in modifying pain-related beliefs and knowledge among children aged 8 to 11 years. The primary outcomes are improvements in pain science knowledge and reductions in fear-avoidance beliefs toward physical activity.

Participants will be recruited from schools participating in the Catalan Board of Physiotherapists' School Health Program. Two primary schools will take part, each contributing two fourth-grade classes. Randomization will be performed at the class level, with classes within each school allocated to either the intervention group (SocLaLola Program) or the control group (Stop Sedentarism Program) using an online random assignment tool. This procedure ensured blocked randomization by school.

Both interventions will be delivered by trained physiotherapists in a single 45-60 minute session. The SocLaLola program combines pain science education with strategies to reduce sedentary behavior, presented through a comic-based narrative. The control group will receive audiovisual materials focusing exclusively on sedentary behavior.

Assessments will be conducted at baseline, immediately after the session, and at six months. Data collection and analysis will follow a single-blind design. Ethical approval for the study was obtained from the Research Ethics Committee of the Catalan Board of Physiotherapists (CER CFC).

Conditions

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Child, Only Musculoskeletal Pain Chronic Pain School Health Sedentary Behaviors Health Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After completing a pilot study, a clinical trial has been designed to evaluate an educational program aimed at preventing musculoskeletal pain in school-aged children. A total of 82 students will be divided into two groups: an intervention group (n = 42), which will participate in the new program 'SocLaLola' incorporating pain science education, and a control group (n = 40), which will follow a conventional sedentary lifestyle prevention program.

Both sessions will be delivered by physiotherapists and will last between 45 and 60 minutes. Evaluations will be conducted immediately after the sessions and again six months later to assess the impact of the program on fear-avoidance beliefs regarding physical activity and on pain science knowledge.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Due to the educational nature of the intervention, it was not possible to blind participants or the physiotherapists delivering the sessions, as they were aware of the content assigned to their group. However, several procedures were implemented to ensure single-blind conditions and minimize potential bias:

* The same physiotherapist delivered the educational sessions for both the intervention and control groups, ensuring consistency in delivery style.
* A different member of the research team was responsible for distributing and collecting the evaluation questionnaires, reducing direct interaction between the educator and the assessment process.
* Data analysis was conducted by an evaluator blinded to group allocation.
* Only the principal investigator had access to the encrypted list linking participant codes to personal identifiers.
* All questionnaires and records were pseudonymized using unique alphanumeric codes to preserve confidentiality and ensure data protection.

Study Groups

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SocLaLola Program

Combines an explanation with the comic-based story SocLaLola to teach basic concepts of pain science education and sedentary behavior prevention in an engaging and age-appropriate way.

Group Type EXPERIMENTAL

School Health Program

Intervention Type OTHER

Health education interventions of approximately 60 minutes that include a conceptual presentation and a practical component.

Stop Sedentary Behavior

Delivers audiovisual materials focusing exclusively on sedentary behavior prevention, without content related to pain science education.

Group Type ACTIVE_COMPARATOR

School Health Program

Intervention Type OTHER

Health education interventions of approximately 60 minutes that include a conceptual presentation and a practical component.

Interventions

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School Health Program

Health education interventions of approximately 60 minutes that include a conceptual presentation and a practical component.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Boys and girls from 8 to 11 years old.
* Attend the 3rd or 4th grade of primary education.
* Students from selected schools participating in the CFC project.
* Their parents or legal guardians have signed the informed consent

* Does not demonstrate reading comprehension in Catalan or Spanish.
* Does not wish to participate.

Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes