Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000793415
Ethics application status
Approved
Date submitted
13/06/2025
Date registered
25/07/2025
Date last updated
25/07/2025
Date data sharing statement initially provided
25/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 314027 0
APP2017114
Universal Trial Number (UTN)
Trial acronym
PAIN SMART Main Trial - Part 1
Linked study record
The registration record ACTRN12624000253505 is the feasibility study for this current study

Health condition
Health condition(s) or problem(s) studied:
Pain 336773 0
Condition category
Condition code
Public Health 333263 333263 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330607 0
Treatment: Other
Intervention code [2] 331389 0
Behaviour
Comparator / control treatment
The control group will receive a one-page list of resources about pain, such as websites to access additional information.
Control group
Active

Outcomes
Primary outcome [1] 340829 0
Pain understanding
Timepoint [1] 340829 0
3 months post-intervention commencement
Secondary outcome [1] 445183 0
Pain understanding
Timepoint [1] 445183 0
12 months post-intervention commencement
Secondary outcome [2] 445184 0
Pain bothersomeness
Timepoint [2] 445184 0
3 and 12 months post-intervention commencement
Secondary outcome [3] 445185 0
Pain interference
Timepoint [3] 445185 0
3 and 12 months post-intervention commencement
Secondary outcome [4] 445187 0
Depression and anxiety - This will be assessed as a composite outcome
Timepoint [4] 445187 0
3 and 12 months post-intervention commencement
Secondary outcome [5] 445189 0
Alcohol consumption and smoking behaviours - This will be assessed as a composite outcome
Timepoint [5] 445189 0
3 and 12 months post-intervention commencement

Eligibility
Key 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.
Minimum age
11 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools for Specific Purposes (i.e., specialised educational settings for students with moderate to high learning and support needs) will be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Schools will be randomly allocated (1:1) to the pain education intervention or to the control group. When a school agrees to participate in the study, they will be randomised by the statistician as per the schedule. This will ensure allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician who is not involved in recruitment will generate a randomization schedule on Microsoft Excel, which will be input to the REDCap database.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarise the characteristics of the sample. Continuous data will be summarised with means and standard deviation, or medians and IQR as appropriate, categorical data will be summarised with counts and proportions. The mean difference between groups in scores at 3 months (and 12 months as secondary outcome) will be estimated with a linear mixed model that includes a random intercept for each study site to adjust for cluster randomisation. The analysis will be completed using all available data under the intention-to-treat approach, with alpha=0.05. These main analyses will be robust to data that is missing-at-random, and we will consider the effect of data that is missing-not-at-random by a tipping point analysis with controlled imputations and a shift parameter that represents plausible scenarios. Before the database is locked, a detailed statistical analysis plan will be prepared by blinded investigators and registered in an appropriate repository.
A similar linear mixed model to the main analysis will be used for continuous secondary outcomes. A generalised linear mixed model (with logit link and binary distribution) will be used for binary secondary endpoints. Continuous data will be summarised with means and standard deviation, or medians and IQR as appropriate, categorical data will be summarised with counts and proportions.
A sensitivity analysis will be conducted for the 12-month outcome measures to estimate the effect of the pain education without potential contamination of the biopsychosocial case management in trial 2. To do this, adolescents who report pain and are randomised to receive biopsychosocial case management in trial 2 will be removed from the sensitivity analysis for trial 1.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2025
Actual
Date of last participant enrolment
Anticipated
3/08/2026
Actual
Date of last data collection
Anticipated
2/08/2027
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318532 0
Government body
Name [1] 318532 0
The Commonwealth of Australia Medical Research Future Fund (MRFF) for Research Activities
Country [1] 318532 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320925 0
Government body
Name [1] 320925 0
NHRMC
Address [1] 320925 0
Country [1] 320925 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317135 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 317135 0
Ethics committee country [1] 317135 0
Australia
Date submitted for ethics approval [1] 317135 0
22/11/2024
Approval date [1] 317135 0
12/02/2025
Ethics approval number [1] 317135 0
2024/HE001772

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140114 0
Dr Tie Parma Yamato
Address 140114 0
The University of Sydney - 62 Derby St, Kingswood, NSW 2747, Australia
Country 140114 0
Australia
Phone 140114 0
+61 0404138248
Fax 140114 0
Email 140114 0
[email protected]
Contact person for public queries
Name 140115 0
Tie Parma Yamato
Address 140115 0
The University of Sydney - 62 Derby St, Kingswood, NSW 2747, Australia
Country 140115 0
Australia
Phone 140115 0
+61 0404138248
Fax 140115 0
Email 140115 0
[email protected]
Contact person for scientific queries
Name 140116 0
Tie Parma Yamato
Address 140116 0
The University of Sydney - 62 Derby St, Kingswood, NSW 2747, Australia
Country 140116 0
Australia
Phone 140116 0
+61 0404138248
Fax 140116 0
Email 140116 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.