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Pain Smart: Integrating pain education and case management for adolescents with pain at schools. Part 1 of a Protocol for a Combined Cluster Randomised Controlled Trial and Individually-Randomised Controlled Trial.

Pain Smart: Integrating pain education and case management for adolescents with pain at schools. Part 1 of a Protocol for a Combined Cluster Randomised Controlled Trial and Individually-Randomised Controlled Trial.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000793415
Acronym
PAIN SMART Main Trial - Part 1
Enrollment
3000
Registered
2025-07-25
Start date
2025-08-04
Completion date
2026-08-03
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is part of a combined cluster randomized controlled trial and individually-randomized controlled trial with embedded clinimetric study. Trial Part 1 is a cluster randomised controlled trial delivering pain education to adolescents attending Australian secondary schools. The cluster randomized controlled trial (1:1 ratio) will be conducted in grades 7-10 in Australian secondary schools. Schools will be randomized to receive 1) a pain education module integrated into the Personal Development, Health and Physical Education (PDHPE) curriculum, or 2) no education. Schools randomized to receive no education will receive the module one year after the study period. A cluster-randomised design, with the school as the unit of randomisation, was chosen to minimise cross-group contamination through staff and student communication.

Interventions

Pain education module vs. No Pain education module The Pain Smart education module includes evidence-based information about pain and pain management aligned with the biopsychosocial model of pain. The development of the module was informed by interviews and a survey of Australian adolescents to explore what they know about pain and their preferences for learning about pain at school. The findings from these studies were integrated with current scientific information about pain to develop the ed

Pain education module vs. No Pain education module The Pain Smart education module includes evidence-based information about pain and pain management aligned with the biopsychosocial model of pain. The development of the module was informed by interviews and a survey of Australian adolescents to explore what they know about pain and their preferences for learning about pain at school. The findings from these studies were integrated with current scientific information about pain to develop the education module. We collaborated with education specialists with expertise in curriculum development to align content with the NSW PDHPE curriculum and mapped the module to the current NSW PDHPE syllabus. The education module was piloted in 312 students in grades 8-10 and 9 PDHPE teachers at two Australian secondary schools. The Pain Smart education module includes three one-hour lessons about pain and pain management: 1) understanding pain and its impact, 2) impact of pain on the whole person, and 3) smart and healthy ways to manage pain. Based on feedback from the feasibility study, we developed a four-lesson option to allocate more time to understanding the biopsychosocial model and applying it to pain. The Pain Smart education module is general in nature with no individual content. The module will be embedded in the curriculum and delivered to the students by PDHPE teachers during usual PDHPE classes once per week over three or four weeks (depending on the three or four lesson version, according to school preferences). The teachers will receive an education module package from the study investigators including: three or four PowerPoint presentations (one for each lesson), a student workbook, a teacher handbook and a module outline aligning content with learning outcomes in stages 4 and 5 of the NSW PDHPE curriculum. Teachers will participate in a 1-hour training session with the study investigators prior to delivering the lessons about pain education and biopsychosocial management for pain. This will ensure all teachers understand the content and deliver the module as intended. The learning activities align with the Interactive-Constructive-Active-Passive Framework for cognitive engagement in learning which suggests learning increases with greater engagement in learning materials. For example, activities include watching an educational video and taking notes followed by a guided class discussion, and working in pairs to read case studies about pain, identify biopsychosocial factors in each case study and compare the case studies using a Venn diagram. Given parents strongly influence how their children learn to respond to pain, caregivers will be invited to attend information sessions about the study and will receive PDF summary of key concepts from the education module.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
11 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

Eligible schools will be secondary schools in New South Wales, Australia with students in grades 7-10. Schools for Specific Purposes (i.e., specialised educational settings for students with moderate to high learning and support needs) will be excluded. Participants will be consenting students attending the selected schools in grades 7-10 (ages 11-16). All students attending participating schools will complete data collection during PDHPE class and all students attending schools allocated to the intervention arm will receive the pain education module. We will seek consent from parents and adolescents to use their data in our study. No students attending the study schools will be excluded from the study. Students with language or learning difficulties will be supported by the schools’ Learning Support Officer.

Exclusion criteria

Schools for Specific Purposes (i.e., specialised educational settings for students with moderate to high learning and support needs) will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 3, 2026