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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SocLaLola Program | Experimental | 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. |
|
| Stop Sedentary Behavior | Active Comparator | Delivers audiovisual materials focusing exclusively on sedentary behavior prevention, without content related to pain science education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| School Health Program | Other | Health education interventions of approximately 60 minutes that include a conceptual presentation and a practical component. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Neuroscience Knowledge (COPAQ) Score | Change in pain neuroscience knowledge will be assessed using the validated Catalan version of the COnocimientos sobre el PAin Questionnaire (COPAQ) for children. The instrument contains 15 items with response options: true, false, or don't know. Total scores range from 0 to 15, with higher scores indicating greater knowledge of pain science. | At baseline (before intervention), immediately after intervention (same day), and at 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fear-Avoidance Beliefs Regarding Physical Activity (FABQ-PA) Score | Change in fear-avoidance beliefs will be assessed using the short Spanish version of the Fear-Avoidance Beliefs Questionnaire - Physical Activity subscale (FABQ-PA), adapted for children. The scale includes 5 items rated on a Likert scale from 0 (completely disagree) to 6 (completely agree). Total scores range from 0 to 24, with higher scores indicating greater fear-avoidance beliefs. A score above 14 is considered high fear-avoidance. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clara Bergé, MSc, PT | Universitat de Lleida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lleida | Lleida | 25001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33949051 | Background | Kisling S, Claus BB, Stahlschmidt L, Wager J. The efficacy of an educational movie to improve pain and dysfunctional behavior in school children: A randomized controlled trial. Eur J Pain. 2021 Aug;25(7):1612-1621. doi: 10.1002/ejp.1777. Epub 2021 May 5. | |
| 32585914 | Background | Louw A, Landrus R, Podolak J, Benz P, DeLorenzo J, Davis C, Rogers A, Cooper K, Louw C, Zimney K, Puentedura EJ, Landers MR. Behavior Change Following Pain Neuroscience Education in Middle Schools: A Public Health Trial. Int J Environ Res Public Health. 2020 Jun 23;17(12):4505. doi: 10.3390/ijerph17124505. |
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Individual participant data (IPD) underlying the results reported in this trial will be shared in de-identified form. Specifically, the datasets will include socio-demographic variables (age, sex, school, cohabitant pain history), responses to the Fear-Avoidance Beliefs Questionnaire (FABQ-PA), responses to the Conceptualization of Pain Questionnaire (COPAQ), and answers to the open-ended post-intervention question. All data will be pseudonymized with unique alphanumeric codes, ensuring that no personally identifiable information will be disclosed. Study protocol, statistical analysis plan, and informed consent templates will also be made available to support secondary analyses. Access to the data will require a justified request and approval by the principal investigator, and data will be shared through secure institutional repositories in accordance with ethical guidelines and data protection regulations (GDPR).
De-identified IPD and supporting documents (Study Protocol, SAP, ICF) will be available beginning 12 months after publication of the primary results and will remain accessible for a period of 5 years through secure institutional repositories, upon reasonable request and approval by the principal investigator.
De-identified individual participant data (IPD) and supporting documents (Study Protocol, Statistical Analysis Plan, and Informed Consent Form) will be accessible to qualified researchers affiliated with academic institutions or health research organizations, for the purpose of scientific research related to pain science education, musculoskeletal health, or school-based interventions. Access will be granted upon submission of a justified research proposal, review and approval by the principal investigator, and signature of a data access agreement. Data will be shared through secure institutional repositories in accordance with ethical standards and data protection regulations (GDPR).
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D059350 | Chronic Pain |
| D057185 | Sedentary Behavior |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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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.
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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:
| At baseline (before intervention), immediately after intervention (same day), and at 6 months follow-up) |
| Association Between Sociodemographic Factors and Changes in Outcome Scores | Sociodemographic variables (age, gender, school, and reported musculoskeletal pain in household members during the past three months) will be collected and analyzed as potential modifiers of changes in FABQ-PA and COPAQ scores over time. | At baseline (before intervention), immediately after intervention (same day), and at 6 months follow-up |
| Children's Perceived Learning After the Educational Session | Students will respond to the open-ended question "What do you think you learned from today's physiotherapist session?" immediately following the intervention. Qualitative responses will be analyzed thematically to explore perceived knowledge acquisition and engagement. | Immediately after intervention (same day) |
| 32845380 | Background | Kedra A, Plandowska M, Kedra P, Czaprowski D. Physical activity and low back pain in children and adolescents: a systematic review. Eur Spine J. 2021 Apr;30(4):946-956. doi: 10.1007/s00586-020-06575-5. Epub 2020 Aug 26. |
| 27525834 | Background | Huguet A, Tougas ME, Hayden J, McGrath PJ, Stinson JN, Chambers CT. Systematic review with meta-analysis of childhood and adolescent risk and prognostic factors for musculoskeletal pain. Pain. 2016 Dec;157(12):2640-2656. doi: 10.1097/j.pain.0000000000000685. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |