Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000253505
Ethics application status
Approved
Date submitted
14/02/2024
Date registered
14/03/2024
Date last updated
14/03/2024
Date data sharing statement initially provided
14/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain Smart: Integrating pain education and clinical care for adolescents with pain at schools.
Scientific title
Pain Smart: Integrating pain education and clinical care for adolescents with pain at schools.
Secondary ID [1] 311289 0
APP2017114
Universal Trial Number (UTN)
Trial acronym
PAIN SMART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 332528 0
Condition category
Condition code
Public Health 329218 329218 0 0
Health promotion/education
Anaesthesiology 329762 329762 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Pain education module and parents resources
The Pain Smart education module contains evidence-based information about pain aligned with the biopsychosocial model. Module content has been informed by previous studies about adolescents’ understanding of and experiences with pain, and their preferences for learning about pain conducted prior to this study. The module has been designed in collaboration with education specialists to ensure congruence with the NSW Personal Development, Health and Physical Education (PDHPE) curriculum, and mapped to the current NSW PDHPE syllabus.
Students in both schools will receive three to four lessons to develop their knowledge and understanding of pain, factors that influence the experience of pain and strategies to manage pain. The pain education will be general in nature with no individual content or tailoring. The delivery of the lessons will be multimodal; including teacher presentations, videos, class discussions, and individual and learning activities designed by an education specialist. The lesson content will be provided by the research team to the PDHPE teachers at participating schools. The PDHPE teachers will deliver the content to the students during usual PDHPE classes, one hour per week, for 4 consecutive weeks during one school term.
Given parents strongly influence how their children learn to respond to pain, a PDF summary of key concepts from the education module will be emailed to the parents within the first week of education module. Lesson attendance marked by the teacher will be used to monitor adherence.

Arm 2: Pain education module and parents resources + Biopsychosocial Care
Students in school B who report pain that impacts their lives at baseline will be contacted by a study case manager.
A registered health professional with experience treating chronic pain will serve as a case manager for students who report problems with pain. The intervention will be consistent with the WHO guidelines for management of chronic pain in children; biopsychosocial assessment and management, care given by healthcare providers skilled and experienced in chronic pain, comprehensive and integrated care, and an interdisciplinary, multimodal approach to pain management. The telehealth consults with the case manager for assessment an care will be conducted on a secure videoconferencing platform. It will be at the discretion of the student if their parent is present during the consult. Care will be provided through one 30 min consult per week, over a one-month period (4 weeks) and tailored to individual needs. The case manager will record attendance to monitor adherence.

The case manager will:
1. Conduct a biopsychosocial assessment, including screening for serious pathology that requires urgent medical attention and mental health.
2. Provide validation, reassurance and information consistent with the participant’s condition and the pain education module.
3. Use principles of goal setting, cognitive behavioural therapy, and motivational interviewing to help the adolescent recover from their condition and return to usual activities.
4. Refer to other health professionals, specialist services and/or further investigations as required.
If pain has resolved by the time the case manager contacts the student, the student declines case management or the case manager assesses the student does not require further follow up, no further management will be provided.

Arm 3: No intervention
Intervention code [1] 327737 0
Treatment: Other
Comparator / control treatment
Control group will receive the same intervention after the end of the study (after the 12 month follow up), but no intervention during the study period. They will continue to receive their usual PDHPE lessons from the NSW curriculum.
Control group
Active

Outcomes
Primary outcome [1] 337276 0
Chronic Pain Risk
Timepoint [1] 337276 0
Baseline, 3-month and 12-month post-intervention commencement
Primary outcome [2] 337277 0
Pain interference
Timepoint [2] 337277 0
Baseline, 3-month and 12-month post-intervention commencement
Primary outcome [3] 337278 0
Pain understanding
Timepoint [3] 337278 0
Baseline, 3-month and 12-month post-intervention commencement
Secondary outcome [1] 431298 0
Health-related quality of Life
Timepoint [1] 431298 0
Baseline, 3-month and 12-month post-intervention commencement
Secondary outcome [2] 431299 0
Depression and anxiety (composite secondary outcome)
Timepoint [2] 431299 0
Baseline, 3-month and 12-month post-intervention commencement
Secondary outcome [3] 431300 0
School absence due to pain
Timepoint [3] 431300 0
Baseline, 3-month and 12-month post-intervention commencement
Secondary outcome [4] 431301 0
Alcohol consumption and smoking behaviours (composite secondary outcome)
Timepoint [4] 431301 0
Baseline, 3-month and 12-month post-intervention commencement
Secondary outcome [5] 431302 0
Physical activity and sedentary behaviours (composite secondary outcome)
Timepoint [5] 431302 0
Baseline, 3-month and 12-month post-intervention commencement

Eligibility
Key inclusion criteria
Participants will be students attending mainstream secondary schools in years 7-9 (ages 11-15). Selection of this participant age group is pragmatic, correlating with the first three years of secondary school and stages 4 and 5 of the New South Wales (NSW) Personal Development, Health, and Physical Education (PDHPE) syllabus. All students will receive the pain education module as part of their usual PDHPE class and data will be collected from consenting students and respective parents/caregivers. Students with language difficulties will be supported by the schools’ Learning Support Officer.
Minimum age
11 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No students attending the study schools will be excluded from the study.

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)
The allocation concealment will be performed through a central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence generation will be performed using a simple randomisation using a randomisation table created by computer software (i.e. computerised sequence
generation)
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2024
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] 315542 0
Government body
Name [1] 315542 0
The Commonwealth of Australia Medical Research Future Fund (MRFF) for Research Activities
Country [1] 315542 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Level 3, Margaret Telfer Building, K07, 79 Arundel Street, Forest Lodge NSW 2037
Country
Australia
Secondary sponsor category [1] 317629 0
Government body
Name [1] 317629 0
NHRMC
Address [1] 317629 0
Country [1] 317629 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314442 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 314442 0
https://www.sydney.edu.au/research/research-integrity-and-ethics.html
Ethics committee country [1] 314442 0
Australia
Date submitted for ethics approval [1] 314442 0
25/09/2023
Approval date [1] 314442 0
06/11/2023
Ethics approval number [1] 314442 0
2023/781

Summary
Brief summary
This study is a multi-site parallel group cluster randomized trial delivering pain education and biopsychosocial care to students attending secondary schools. This school-based intervention aims to provide the opportunity for all adolescents to access accurate and evidence-based information about pain and pain management. This study is a three-arm parallel group cluster randomized trial, with economic evaluation. Participating schools will be randomly allocated to 1) pain education module and parent resources, 2) pain education module and parent resources, plus biopsychosocial care for students reporting problems with pain, or 3) no intervention.
Trial website
painsmart-education.sydney.edu.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131598 0
Prof Steven Kamper
Address 131598 0
The University of Sydney and NBMLHD - 62 Derby St, Kingswood, NSW 2747, Australia
Country 131598 0
Australia
Phone 131598 0
+61 0411383044
Fax 131598 0
Email 131598 0
steven.kamper@sydney.edu.au
Contact person for public queries
Name 131599 0
Dr Tie Parma Yamato
Address 131599 0
The University of Sydney and NBMLHD - 62 Derby St, Kingswood, NSW 2747, Australia
Country 131599 0
Australia
Phone 131599 0
+61 0404138248
Fax 131599 0
Email 131599 0
tie.yamato@sydney.edu.au
Contact person for scientific queries
Name 131600 0
Dr Tie Parma Yamato
Address 131600 0
The University of Sydney and NBMLHD - 62 Derby St, Kingswood, NSW 2747, Australia
Country 131600 0
Australia
Phone 131600 0
+61 0404138248
Fax 131600 0
Email 131600 0
tie.yamato@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.