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

U

Universitat de Lleida

Status

Completed

Conditions

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

Treatments

Other: School Health Program

Study type

Interventional

Funder types

Other

Identifiers

NCT07160478
SocLaLola_ULleida

Details and patient eligibility

About

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.

Full 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).

Enrollment

82 patients

Sex

All

Ages

8 to 11 years old

Volunteers

Accepts Healthy Volunteers

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

Exclusion criteria

  • Does not meet one or more inclusion criteria.
  • Does not demonstrate reading comprehension in Catalan or Spanish.
  • Does not wish to participate.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

82 participants in 2 patient groups

SocLaLola Program
Experimental group
Description:
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.
Treatment:
Other: School Health Program
Stop Sedentary Behavior
Active Comparator group
Description:
Delivers audiovisual materials focusing exclusively on sedentary behavior prevention, without content related to pain science education.
Treatment:
Other: School Health Program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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