Clinical Trials Directory

Trials / Completed

CompletedNCT07160478

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

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: Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
82 (actual)
Sponsor
Universitat de Lleida · Academic / Other
Sex
All
Age
8 Years – 11 Years
Healthy volunteers
Accepted

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 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

Interventions

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

Timeline

Start date
2022-02-10
Primary completion
2025-08-10
Completion
2025-08-10
First posted
2025-09-08
Last updated
2026-01-29

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07160478. Inclusion in this directory is not an endorsement.