Health Education, Musculoskeletal Pain, School Health, Sedentary Behaviors
Conditions
Keywords
pain beliefs, pain education, children, muskuloskeletal pain, Fear-Avoidance, sedentary behaviors, Musculoskeletal pain prevention, primary school, School health program, pain science education
Brief summary
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.
Detailed description
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 was performed at the class level (cluster randomization), stratified by school. Within each of the two participating schools, the two fourth-grade classes were randomly allocated, one to the intervention group (SocLaLola Program) and one to the control group (Stop Sedentarism Program), using the online randomization service Sealed Envelope (Sealed Envelope Ltd, London, UK). Allocation was concealed from the outcome assessor. 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).
Interventions
OTHERSchool Health Program
Health education interventions of approximately 60 minutes that include a conceptual presentation and a practical component.
Sponsors
Universitat de Lleida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Cluster randomized controlled trial with allocation at the class level. Following a pilot study, this trial evaluated a school-based program to prevent musculoskeletal pain in children. Four fourth-grade classes from two primary schools were randomized, stratified by school, with one class per school allocated to each arm (two clusters per arm), using Sealed Envelope (London, UK). Of the 82 students included, 42 formed the intervention group, which received the "SocLaLola" program incorporating pain science education, and 40 the control group, which received a conventional sedentary behavior prevention program. Both sessions were delivered by trained physiotherapists and lasted 45-60 minutes. Participants were assessed at baseline, immediately after the session, and at six months, on pain science knowledge (COPAQ) and fear-avoidance beliefs regarding physical activity (FABQ-PA).
Eligibility
Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Boys and girls from 8 to 11 years old. * Attend the 4th grade of primary education. * Students from selected schools participating in the CFC project. * Their parents or legal guardians have signed the informed consent
Exclusion criteria
* Does not meet one or more inclusion criteria. * Does not demonstrate reading comprehension in Catalan or Spanish. * Does not wish to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Neuroscience Knowledge (COPAQ) Score | At baseline (before intervention), immediately after intervention (same day), and at 6 months follow-up | Change in pain neuroscience knowledge will be assessed using the validated Catalan version of the Conceptualization of 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fear-Avoidance Beliefs Regarding Physical Activity (FABQ-PA) Score | At baseline (before intervention), immediately after intervention (same day), and at 6 months follow-up) | 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. |
| Association Between Sociodemographic Factors and Changes in Outcome Scores | At baseline (before intervention), immediately after intervention (same day), and at 6 months follow-up | 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. |
| Children's Perceived Learning After the Educational Session | Immediately after intervention (same day) | 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. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORClara Bergé, MSc, PT
Universitat de Lleida
Outcome results
None listed