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Trial registered on ANZCTR
Registration number
ACTRN12625000044426p
Ethics application status
Submitted, not yet approved
Date submitted
5/11/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Taking the plunge. Combined education and learning to swim for low back pain
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Scientific title
Taking the plunge. Combined education and learning to swim for adults with persistent low back pain
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Secondary ID [1]
313315
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RSH/6802
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Low back pain
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Condition category
Condition code
Musculoskeletal
332227
332227
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0
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Other muscular and skeletal disorders
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Physical Medicine / Rehabilitation
332448
332448
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
- Brief educational messages provided to participants. These are readily available video / online resources (reference list below):
1. 'Tame the Beast: It’s Time to Rethink Persistent Pain" is designed to educate viewers on the neuroscience behind persistent pain, encouraging a shift in mindset about pain as a brain-based experience. It highlights concepts like neuroplasticity, emotional influence, and the brain's role in pain perception to empower viewers in managing chronic pain.
2. "Understanding Pain in Less than 5 Minutes" explains how pain works and the factors that influence it, while offering strategies to manage pain more effectively. It is aimed at helping individuals, especially parents and healthcare providers, to better understand pain and improve patient outcomes.
These videos were assessed and considered of ‘high user engagement’ (1) and are freely available for the public and knowingly focus on simplified explanations and engaging formats like animations, thus making made complex topics accessible and engaging.
References:
1. Heathcote LC, Pate JW, Park AL, Leake HB, Moseley GL, Kronman CA, et al. Pain neuroscience education on YouTube. PeerJ. 2019;7:e6603.
- Participants will be asked to watch both videos prior to commencing the learn to swim program
- learn to swim program comprising 8 weeks, 2 x week for 30 minutes duration
- learn to swim supervised and taught by a qualified learnt to swim teacher or accredited swimming coach
- lesson contents include but not limited to:
* Water Familiarization
* Breath Control and Submersion
* Floating and Buoyancy
* Kicking and Arm Movements
* Body Position and Streamlining
* Stroke Development
* Basic Safety and Survival Skills
* Gradual Distance Swimming
- lessons will be conducted at approved urban and regional aquatic centers face-to-face
- people with back pain may be either in a group or individual session, depending on participant and instructor time and availability.
- instructor will take note of and document participant attendance.
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Intervention code [1]
329891
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Rehabilitation
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Recruitment
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Assessment method [1]
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Rate or percentage of participants recruited within a specific time frame of 3 months. Logged via use of a spreadsheet (e.g., Excel) Key Columns will include: *Date of recruitment *Participant ID (anonymized) *Recruitment source or method *Status (e.g., consented, enrolled) To be record regularly: Update the log daily or weekly to ensure accurate tracking.
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Timepoint [1]
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Tracked continuously throughout the recruitment period, e.g. scheduled to occur once every week, starting from the initiation of the intervention, and will continue weekly for a total of twelve weeks after the intervention (recruitment) begins.
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Primary outcome [2]
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Retention
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Assessment method [2]
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Proportion of participants who complete the study. Ensure the attendance log includes essential details, such as: *Date and time of class *Participant names or IDs *Attendance status (e.g., present, absent, excused)
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Timepoint [2]
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At the end of study period (8 weeks)
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Primary outcome [3]
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Participant acceptability to the intervention.
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Assessment method [3]
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Using semi structured interviews (one-on-one) of 30 minutes duration to assess acceptability; 1. provide details / reasons for participating in the learn to swim program 2. relevance (or suitability) for the learn to swim program 3. thoughts on the study questionnaires and data collection methods 4. what made it easy (facilitator) or difficult (barrier) to participate in the study 5. (pain) education videos improved (or did not improve) back pain in the context of the learn to swim program
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Timepoint [3]
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End of study e.g., 8 weeks.
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Secondary outcome [1]
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Fear avoidance behaviour
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Assessment method [1]
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Fear-Avoidance Behaviour Questionnaire
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Timepoint [1]
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Baseline and 3 months post intervention commencement
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Secondary outcome [2]
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Physical activity
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Assessment method [2]
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The Physical Activity and Sedentary Behaviour Questionnaire (PASB-Q)
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Timepoint [2]
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Baseline and 3 months post intervention commencement
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Secondary outcome [3]
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Pain
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Assessment method [3]
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Pain intensity: Numeric Pain Rating Scale
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Timepoint [3]
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Baseline and 3 months post intervention commencement
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Secondary outcome [4]
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Disability
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Assessment method [4]
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Disability: Oswestry Disability Index
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Timepoint [4]
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Baseline and 3 months post intervention commencement
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Secondary outcome [5]
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Pain self-efficacy
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Assessment method [5]
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Pain self-efficacy questionnaire
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Timepoint [5]
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Baseline and 3 months post intervention commencement
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Adults aged 18 years +
2. Persistent low back pain (LBP) >12 weeks
3. Pain intensity >2/10 (numerical pain rating scale (NPRS)
4. Desire to learn to swim
5. Able to complete pain education program
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
1. Inability to comprehend written English
2. Recent lumbar spine surgery
3. Signs and symptoms indicative of serious pathology causing LBP (bowel or bladder dysfunction, change in sensation in the perineal region, worsening pain at night, recent fevers/illness, or recent worsening of neurological symptoms in the lower legs, i.e., pins and needles, numbness, sensory loss, muscle weakness).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
The primary aim of this feasibility study is to assess the practicality of conducting a full-scale trial rather than to draw definitive statistical conclusions. Descriptive statistics (e.g., means, medians, proportions) will be used to summarize key feasibility outcomes, including recruitment rates, retention rates, and adherence to the intervention. Simple inferential statistics (e.g., confidence intervals) may be applied where appropriate to assess variability and guide sample size calculations for future studies. The sample size for this study is based on feasibility considerations rather than statistical power, ensuring sufficient representation to explore logistical challenges and refine study protocols.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/03/2025
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Actual
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Date of last participant enrolment
Anticipated
1/06/2025
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Actual
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Date of last data collection
Anticipated
1/09/2025
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Actual
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Sample size
Target
15
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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CQUniversity
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
CQUniversity
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320082
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Country [1]
320082
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
316454
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CQ University's Human Research Ethics Committee
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Ethics committee address [1]
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https://www.cqu.edu.au/research/current-research/ethics-committees/human-research-ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/11/2024
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Approval date [1]
316454
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Ethics approval number [1]
316454
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Summary
Brief summary
This single-arm feasibility trial evaluates the acceptability and practicality of an 8-week intervention combining a structured learn to swim program and (pain) educational sessions aimed at reducing LBP. Participants with LBP will engage in supervised swimming lessons, complemented by an educational content on pain management, physical activity benefits, and self-care strategies. The latter will comprise of two short videos. Primary objective(s) is to assess feasibility indicators, including recruitment and retention rates, adherence to learning to swim, and fidelity of the education sessions. Secondary objectives explore outcomes related to preliminary effects on pain intensity, disability, self-efficacy, fear behaviors and physical activity levels to inform the potential clinical benefits of the program. Hypothesis: This feasibility and small single-arm trial will show participant recruitment, retention and baseline data completion along with follow up rates to be within pre-determined levels. Further, participants will show trends towards greater self-efficacy (belief), and reduced pain and disability - associated with participation in an education and learn to swim program.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Matthew Fernandez
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Address
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CQUniversity Australia, Level 20, 160 Ann St, Brisbane QLD 4000
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Country
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Australia
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Phone
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+61 07 3023 4279
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Matthew Fernandez
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Address
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CQUniversity Australia, Level 20, 160 Ann St, Brisbane QLD 4000
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Country
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Australia
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Phone
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+61 07 3023 4279
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Matthew Fernandez
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Address
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CQUniversity Australia, Level 20, 160 Ann St, Brisbane QLD 4000
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Country
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Australia
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Phone
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+61 07 3023 4279
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Feasibility trials like this one proposed will have a small sample size and focus on determining whether a study design is workable, rather than providing robust conclusions about efficacy. Thus, the benefits of IPD sharing will be limited in this context.
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
Protocol
CQU Ethics Protocol.docx
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.
Download to PDF