Effectiveness of the Soc la Lola School Health Education Program on Beliefs and Knowledge About Musculoskeletal Pain Management in 8-11-Year-Old Primary School Students: Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change in Pain Neuroscience Knowledge (COPAQ) Score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Does not meet one or more inclusion criteria.
- •Does not demonstrate reading comprehension in Catalan or Spanish.
- •Does not wish to participate.
研究组 & 干预措施
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.
干预措施: School Health Program (Other)
Stop Sedentary Behavior
Delivers audiovisual materials focusing exclusively on sedentary behavior prevention, without content related to pain science education.
干预措施: School Health Program (Other)
结局指标
主要结局
Change in Pain Neuroscience Knowledge (COPAQ) Score
时间窗: 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.
次要结局
- 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))
- Association Between Sociodemographic Factors and Changes in Outcome Scores(At baseline (before intervention), immediately after intervention (same day), and at 6 months follow-up)
- Children's Perceived Learning After the Educational Session(Immediately after intervention (same day))
研究者
Clara Bergé Ortínez
Principal Investigator, Associate Professor at the University of Lleida
Universitat de Lleida