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Pain Smart: Integrating pain education and case management for adolescents with pain at schools. Part 2 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 2 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
ACTRN12625000794404
Acronym
PAIN SMART Main Trial - Part 2
Enrollment
206
Registered
2025-07-25
Start date
2025-11-04
Completion date
2026-11-02
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 a combined cluster randomized controlled trial and individually-randomized controlled trial with embedded clinimetric study. Trial Part 2 is an individually-randomized controlled trial delivering biopsychosocial case management to adolescents with bothersome pain attending Australia secondary schools. The individually-randomized controlled trial (1:1 ratio) will be conducted in adolescents in grades 7-10 attending Australian secondary schools. Adolescents reporting bothersome pain at baseline will be randomized to receive a) biopsychosocial case management and facilitated referral, or 2) no intervention. Participants in Trial Part 2 will be recruited from schools in Trial Part 1.

Interventions

Pain SmartER vc No Pain SmartER Pain SmartER (Extended Resources) case management is an opportunity for adolescents to access additional biopsychosocial advice, support and guidance for their pain. It is an individually tailored extension of the content to be provided in the Pain Smart education module. Pain SmartER case management aims to reduce pain interference among participants by building self-efficacy to manage pain and navigating continuation and return to usual activities. Recruitment f

Pain SmartER vc No Pain SmartER Pain SmartER (Extended Resources) case management is an opportunity for adolescents to access additional biopsychosocial advice, support and guidance for their pain. It is an individually tailored extension of the content to be provided in the Pain Smart education module. Pain SmartER case management aims to reduce pain interference among participants by building self-efficacy to manage pain and navigating continuation and return to usual activities. Recruitment for trial 2 will commence after the 3-month follow up in trial 1. Participants will be connected to a Pain Navigator (member of the study team), a registered health professional from our research team with experience managing adolescents with pain. The Pain Navigator and participant will meet via Zoom or phone call for 30 minutes up to four times within a one month period. Session attendance will be used to monitor adherence to the intervention. If the participant declines a Zoom or phone call session, the Pain Navigator will offer to deliver Pain SmartER via SMS or email. Initially, the Pain Navigator will ask the participant questions about their pain, their relevant social and medical history, and how the pain is interfering with their life. The Pain Navigator will also screen for any mental health or serious pathology requiring urgent medical attention. If there is suspicion of serious or specific pathology or mental health condition requiring further assessment, the Pain Navigator will recommend the participant to see a GP and provide a summary letter to the GP. The Pain Navigator will follow up with the participant to determine the outcome of further assessment and provide advice, support and guidance as indicated. Pain SmartER case management will be tailored towards issues, barriers and goals identified by the participant and Pain Navigator during the initial conversation. Using principles of goal setting, cognitive behavioural therapy and motivational interviewing, the subsequent conversations may include: 1. Information and resources about pain and pain management (Pain SmartER Toolkit) 2. Strategies to manage pain and return to usual activities 3. Recommendations for further assessment and/or treatment from other health and medical professionals, including referrals to other services when appropriate. If the participant declines Pain SmartER via Zoom/phone call and SMS/email, the Pain Navigator will offer to send the participant the Pain SmartER Toolkit. The Pain SmartER Toolkit will include written information about pain and strategies to manage pain aligned with the biopsychosocial model. The participant will be advised they can contact the Pain Navigator for further advice, support and guidance as needed. The Pain Navigator will provide a summary of the conversation to the participant’s parent, general practitioner or other health practitioner as required. They will also work with the school nurse and/or school counsellor when required. The Pain SmartER advice, support and guidance will be based on the WHO guidelines for management of pain with children. These guidelines recommend 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.

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

Participants will be adolescents in grades 7-10 (ages 11-16) attending a mainstream Australian secondary school in Sydney participating in Trial Part 1. Eligible participants will be adolescents attending schools allocated to the intervention arm (pain education) in trial 1. Participants reporting bothersome pain, in this study identified as pain that has been ‘some’, ‘a lot’ or ‘a whole lot’ of a problem in the past month on the Paediatric Pain Screening Tool, item 9 at the 3-month follow up survey or the monthly SMS/email follow up assessment at months 4-11 in trial 1, who assent and have parental consent to participate in the study will be eligible. No participants will be excluded.

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: Feb 4, 2026