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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
Scientific title
Biofeedback assisted relaxation training for the management of pain in children with physical disabilities undergoing lower limb orthopaedic surgery
Secondary ID [1] 312810 0
PRG05121
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 334879 0
Anxiety 334880 0
Condition category
Condition code
Surgery 331432 331432 0 0
Other surgery
Anaesthesiology 331854 331854 0 0
Pain management

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329350 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 339188 0
Average pain level
Timepoint [1] 339188 0
Day 1 post operatively to discharge at least once a day
Secondary outcome [1] 438981 0
Average anxiety level
Timepoint [1] 438981 0
Day 1 post-operatively to discharge at least once a day
Secondary outcome [2] 438987 0
Acceptability and feasibility of the allocated intervention for the management of pain and anxiety. This will be assessed as a composite outcome.
Timepoint [2] 438987 0
On discharge from inpatient admission

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.
Minimum age
7 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2026
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317247 0
Charities/Societies/Foundations
Name [1] 317247 0
The Cerebral Palsy Alliance Research Foundation
Country [1] 317247 0
Australia
Primary sponsor type
Hospital
Name
The Sydney Children's Hospitals Network
Address
Country
Australia
Secondary sponsor category [1] 319525 0
None
Name [1] 319525 0
Address [1] 319525 0
Country [1] 319525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315985 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 315985 0
Ethics committee country [1] 315985 0
Australia
Date submitted for ethics approval [1] 315985 0
30/05/2024
Approval date [1] 315985 0
16/08/2024
Ethics approval number [1] 315985 0
2024/ETH00703

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

Contacts
Principal investigator
Name 136422 0
Ms Karen Bau
Address 136422 0
The Children's Hospital at Westmead, Locked Bag 4001, Westmead 2145, NSW Australia
Country 136422 0
Australia
Phone 136422 0
+61 2 78252854
Fax 136422 0
Email 136422 0
karen.bau@health.nsw.gov.au
Contact person for public queries
Name 136423 0
Karen Bau
Address 136423 0
The Children's Hospital at Westmead, Locked Bag 4001, Westmead 2145, NSW Australia
Country 136423 0
Australia
Phone 136423 0
+61 2 78252854
Fax 136423 0
Email 136423 0
karen.bau@health.nsw.gov.au
Contact person for scientific queries
Name 136424 0
Karen Bau
Address 136424 0
The Children's Hospital at Westmead, Locked Bag 4001, Westmead 2145, NSW Australia
Country 136424 0
Australia
Phone 136424 0
+61 2 78252854
Fax 136424 0
Email 136424 0
karen.bau@health.nsw.gov.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.