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Trial registered on ANZCTR
Registration number
ACTRN12624001223527
Ethics application status
Approved
Date submitted
26/08/2024
Date registered
8/10/2024
Date last updated
8/10/2024
Date data sharing statement initially provided
8/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Biofeedback assisted relaxation training for the management of pain in children with physical disabilities undergoing lower limb orthopaedic surgery
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Scientific title
Biofeedback assisted relaxation training for the management of pain in children with physical disabilities undergoing lower limb orthopaedic surgery
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Secondary ID [1]
312810
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PRG05121
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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:
Pain
334879
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Anxiety
334880
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Condition category
Condition code
Surgery
331432
331432
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0
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Other surgery
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Anaesthesiology
331854
331854
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention is Biofeedback Assisted Relaxation Training (BART) delivered via an iOS Application called BrightHearts (BH). BH displays a colourful geometric artwork and sounds on an iPad or iPhone, which changes in response to variations in the individual’s heart rate transmitted by a wireless heart rate sensor worn on the wrist.
Participants in the intervention arm will receive a 30 minute training in the use of BH 4-12 weeks prior to surgery and then another session 2 weeks prior to surgery. It is preferred that the practice session be face to face with a research investigator, however if this cannot occur for any reason e.g. rural, isolated participants, or participants not accessing the hospital within the 4-12 week time period, then an online session will be provided. The family will be able to download the BH App onto their device and a heart rate sensor will be sent to the family. If surgery is cancelled and not rescheduled within 2 weeks another practice session will be provided.
A script will be utilised to standardise training and support the child to engage with the BH App. "Look at the colours on the iPad/phone and listen to the chimes. Begin by taking long slow deep breaths in and out. Breathe in through your nose and out through your nose or mouth. You might become distracted by things around you but try and focus on your breathing. Try and slow your breaths and heart rate. As your breath and heart rate slow, the colours will change from reds and oranges to blues and greens and the chimes will become further apart. Try and keep the colours blue and green. If you can’t change the colours, that is okay, just continue to focus on taking long deep breaths."
Participants will use BH at least once a day during their inpatient admission for painful procedures following orthopaedic surgery from Day 1 post op to discharge. Painful procedures in which BH will be used has been pre determined from clinicians and research advisors with lived experience. Procedures BH can be used for include:
• Bed mobility
• Weight bearing mobilisation (including standing, walking)
• Transfers (both weightbearing and non-weightbearing)
• Plaster cast changes/removals/adjustments
• Orthopaedic hardware removal (not requiring a general anaesthetic)
• Physiotherapy bed exercises/exercise programs
It is anticipated that BH will be used for 5-10 minutes prior to procedures or if used during the procedure, may be used for up to 30mins. It will be documented if BH was used prior or during the procedure. All other routine care such as parent consoling/distraction and pharmacological pain management as prescribed by the appropriate clinical teams will still be provided and documented.
The use of BH will be supported either by the child's parent., a research investigator or clinician. All staff providing and overseeing the implementation of BH will complete training in the use of BH and the outcomes prior. Staff will receive a single training session within a month prior to implementing the intervention and collection of outcome measures. Training will be given either face to face or online with a member of the research team. An information sheet has been developed in order to ensure training is standardised. It is expected that this training will take approximately 30 minutes.
Immediately after the procedure, the participant will complete two self -report outcome measures, the Faces Pain Scale- Revised (FPS-R) and the Faces Anxiety Scale- Child (FAS-C). Participants will rate their overall pain and anxiety level as opposed to the highest level of pain and anxiety due to the varying duration of the procedures. The average admission period is five days. Any pharmacological intervention given will be noted for each procedure.
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Intervention code [1]
329350
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Treatment: Other
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Comparator / control treatment
The control arm is routine non-pharmacological care, which involves the health care professional explaining the procedure to the child and parent/carer. The child may be encouraged to engage in distraction therapy with support from their parent/carer and clinical staff on the ward. Typical examples of distraction therapy used during routine care of procedures following lower limb orthopaedic surgery include music, iPads, toys, or verbal distraction. Children will still be given pharmacological pain management as prescribed by the appropriate medical teams.
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Control group
Active
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Outcomes
Primary outcome [1]
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Average pain level
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Assessment method [1]
339188
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Faces Pain Scale-Revised
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Timepoint [1]
339188
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Day 1 post operatively to discharge at least once a day
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Secondary outcome [1]
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Average anxiety level
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Assessment method [1]
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Faces Anxiety Scale- Child
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Timepoint [1]
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Day 1 post-operatively to discharge at least once a day
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Secondary outcome [2]
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Acceptability and feasibility of the allocated intervention for the management of pain and anxiety. This will be assessed as a composite outcome.
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Assessment method [2]
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Questionnaire designed specifically for this study
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Timepoint [2]
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On discharge from inpatient admission
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Eligibility
Key inclusion criteria
*Diagnosis of a physical disability.
*Undergoing a lower limb orthopaedic surgical procedure. This is defined as
surgery on the muscles or bones of the pelvis, hip, leg, ankle or foot unrelated to trauma.
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Minimum age
7
Years
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Maximum age
19
Years
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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
*Has a diagnosis of a spinal cord injury or spinal anomaly.
*Orthopaedic surgery related to limb difference.
*Child does not speak English and requires an interpreter (If the parent does not speak English this does not exclude participation).
*Has more than a mild intellectual disability.
*Is unable to adequately communicate determined by the Communication Function Classification Scale (CFCS) score IV-V or equivalent.
*Has a severe visual impairment.
*Has already been a participant in the study and undergoing further lower limb orthopaedic surgery
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be conducted independently using a central computer-based randomisation service within REDCap.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised with 50 percent of participants being assigned to each group. Randomisation will be stratified by age at time of enrolment, 7-12 years and 13-19 years. These age groups have been chosen due to developmental differences and represent middle childhood and adolescent age groups.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2024
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Actual
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Date of last participant enrolment
Anticipated
1/10/2026
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Actual
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Date of last data collection
Anticipated
1/06/2027
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Actual
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Sample size
Target
48
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
317247
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Charities/Societies/Foundations
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Name [1]
317247
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The Cerebral Palsy Alliance Research Foundation
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Address [1]
317247
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Country [1]
317247
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Australia
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Primary sponsor type
Hospital
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Name
The Sydney Children's Hospitals Network
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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]
319525
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Address [1]
319525
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Country [1]
319525
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315985
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Sydney Children's Hospitals Network Human Research Ethics Committee
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Ethics committee address [1]
315985
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http://www.schn.health.nsw.gov.au/health-professionals/our-research/ethics-research-governance
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Ethics committee country [1]
315985
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Australia
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Date submitted for ethics approval [1]
315985
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30/05/2024
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Approval date [1]
315985
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16/08/2024
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Ethics approval number [1]
315985
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2024/ETH00703
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Summary
Brief summary
To assess the effectiveness of Biofeedback Assisted Relaxation Training (delivered via the BrightHearts iOS App) plus routine non-pharmacological care compared to routine non-pharmacological care alone for managing pain for procedures following lower limb orthopaedic surgery in children with physical disabilities. It is hypothesized that BrightHearts will assist with decreasing pain levels during procedures performed during the inpatient admission following lower limb orthopaedic surgery.
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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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Ms Karen Bau
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Address
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The Children's Hospital at Westmead, Locked Bag 4001, Westmead 2145, NSW Australia
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Country
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Australia
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Phone
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+61 2 78252854
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Fax
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Email
136422
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[email protected]
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Contact person for public queries
Name
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Karen Bau
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Address
136423
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The Children's Hospital at Westmead, Locked Bag 4001, Westmead 2145, NSW Australia
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Country
136423
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Australia
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Phone
136423
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+61 2 78252854
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Fax
136423
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Email
136423
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[email protected]
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Contact person for scientific queries
Name
136424
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Karen Bau
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Address
136424
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The Children's Hospital at Westmead, Locked Bag 4001, Westmead 2145, NSW Australia
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Country
136424
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Australia
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Phone
136424
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+61 2 78252854
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Fax
136424
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Email
136424
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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