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Trial registered on ANZCTR


Registration number
ACTRN12620000205932
Ethics application status
Approved
Date submitted
14/01/2020
Date registered
20/02/2020
Date last updated
10/11/2021
Date data sharing statement initially provided
20/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
BrightHearts RCT: procedural pain management during botulinum toxin-A injections.
Scientific title
BrightHearts: Evaluating the efficacy of biofeedback mediated relaxation for the management of procedural pain in children undergoing intramuscular botulinum toxin-A injections.
Secondary ID [1] 300245 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 315802 0
acquired brain injury 316286 0
hereditory spastic paraparesis 316287 0
children with neurological physical disability 316288 0
procedural pain 316289 0
Condition category
Condition code
Physical Medicine / Rehabilitation 314095 314095 0 0
Other physical medicine / rehabilitation
Anaesthesiology 314120 314120 0 0
Pain management
Neurological 314561 314561 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised controlled crossover trial of biofeedback assisted relaxation training (BART) (Arm 1) versus distraction therapy (Arm 2) for procedural pain management in children and adolescents with neurological physical disabilities (cerebral palsy, acquired brain injury, hereditary spastic paraparesis) undergoing intramuscular botulinum toxin-A (BoNT-A) injections.

Participants will be self-electing to undergo BoNT-A injections without sedation (nitrous oxide, midazolam, general anasethetic). Participants will be provided topical anesthetic cream and the allocated intervention. Undergoing BoNT-A injections without sedation is a part of routine care at the paediaitric rehabilitation services in New South Wales. Distraction therapy with topical anesthetic cream are provided as part of standard clinical care.

Potential participants and their parent/carer will be provided informational materials by the research investigator. The research investigator will explain and demonstrate both intervention arms to potential participants. Eligible and consenting participants will be randomized to Arm 1 or Arm 2 during the first study period, followed by the alternative intervention arm during their subsequent BoNT-A treatment.

The interventions will be delivered by a trained research investigator with experience conducting clinical research in the field of paediatric neurodevelopmental disability. The interventions will be delivered face-to-face on an individual basis during the BoNT-A injection clinic conducted at a tertiary paediaitric hospital. Participants will receive one intervention arm per BoNT-A injection treatment. The allocated intervention will be used during the medical procedure, and may be used in the waiting room prior to the injection if desired. The allocation intervention will be used during the medical procedure (approximate duration of 5-10 minutes) and may also be used in the waiting room prior to the medical procedure if the participant desires (approximately one hour in waiting time). Therefore the approximate frequency/duration of the intervention is 1 x 1 hour BoNT-A appointment. Adherence to the intervention will be monitored via clinical observation. The length of time between BoNT-A treatments is usually 6 months and may range from 4-12 months. The wash out period is the period between two consecutive BoNT-A treaments (i.e. 4-12 months).

Arm 1: BART is a behavioural therapy whereby an individual learns to voluntarily modulate a biological process (e.g. heart rate) via electromechanical devices that measure physiological parameters and deliver feedback (e.g. auditory, visual). BART will be delivered via BrightHearts, an iOS application. BrightHearts is a heart rate controlled application which displays an interactive geometric artwork changing in response to heart rate variability. Using a wireless heart rate watch, realtime heart rate data is sent to the app using wireless Bluetooth technology. The geometric artwork changes shapes and colours in response to reductions in heart rate. The participant is encouraged to use slow exhalation and focus on relaxing feelings in order to decrease their hear rate, and in turn animate the sounds and visuals of the application. Participants will be provided access to the BrightHearts application through an iPad and the wireless, Bluetooth heart rate sensor (Mio Link device) to send real-time heart rate data. The research investigator will demonstrate how the application works and provide brief 10 minute training on the application in preparation for the treatment (on the day and in the waiting room). Participants will then be asked to practice using the application for a minimum of 10 minutes in preparation for the medical procedure and during the medical procedure. Between routine clinical assessment and injection there is an approximate waiting period of 1 hour to allow topical anaesthetic cream to take effect. Should the participant wish, they may practice using the intervention for more than the minimum 10 minute practice period (up to 1 hour in the waiting room).

Arm 2: Distraction therapy will be based on the participants personal preference. Participants will be provided access to a smart device (ipad) should they desire, or if they do not have access to their own personal smart device. Participants in the distraction therapy group will be encouraged to choose whatever form of distraction therapy they desire (e.g. music, movie, game) as standard care recommends distraction to be catered to the child’s age and preferences. Participants will be asked to engage in distraction therapy during the medical procedure (approximate duration 5-10 minutes). Between routine clinical assessment and injection there is an approximate waiting period of 1 hour to allow topical anaesthetic cream to take effect. Should the participant wish, they may engage in distraction therapy during their time in the waiting room.
Intervention code [1] 316517 0
Treatment: Other
Intervention code [2] 316535 0
Behaviour
Comparator / control treatment
Arm 2: Distraction therapy will be based on the participants personal preference. Participants will be provided access to a smart device (ipad) should they desire or if they do not have access to their own personal smart device. Participants in the distraction therapy group will be encouraged to choose whatever form of distraction therapy they desire (e.g. music, movie, game) as standard care recommends distraction to be catered to the child’s age and preferences.
Control group
Active

Outcomes
Primary outcome [1] 322489 0
Child self-reported pain using the Faces Pain Scale-Revised.
Timepoint [1] 322489 0
Child participants will report the “overall” level of pain and “worst” level of pain experienced during the procedure immediately after the treatment is completed.
Secondary outcome [1] 378678 0
Behavioural assessment of pain Face, Legs, Activity, Cry, Consolability (FLACC) scale
Timepoint [1] 378678 0
The child participant will be observed by the research investigator for behavioural indicators of pain during the first and last injection in each BoNT-A session
Secondary outcome [2] 378679 0
Child self-reported fear using Children’s Fear Scale.
Timepoint [2] 378679 0
At the conclusion of each BoNT-A injection session, the child participant will retrospectively report the overall fear experienced during the BoNT-A injection session and the level of fear they currently associate with the next BoNT-A injection session they will undergo.
Secondary outcome [3] 378680 0
Child self-reported anxiety via the State-Trait Anxiety Inventory for Children
Timepoint [3] 378680 0
The child participant will be asked to complete both the A-State scale and the A-Trait scale before the BoNT-A procedure. The child participant will complete the S-Trait Scale immediately following the completion of the BoNT-A procedure.
Secondary outcome [4] 378693 0
Child participant self-reported anxiety via the Numerical rating scale- State Anxiety (0-10)
Timepoint [4] 378693 0
The child participant will complete the measure before the procedure to assess anticipatory anxiety, and report the overall anxiety experienced during BoNT-A injections at immediately following the completion of the procedure.
Secondary outcome [5] 378694 0
Health care professional report of child participants pain experienced during procedure using numerical rating scale (0-10)
Timepoint [5] 378694 0
Retrospectively reported immediately after each BoNT-A injection session
Secondary outcome [6] 378695 0
Parent/carer report of child participants pain experienced during procedure using numerical rating scale (0-10)
Timepoint [6] 378695 0
Retrospectively reported immediately after each BoNT-A injection session

Eligibility
Key inclusion criteria
• Diagnosis of cerebral palsy, acquired brain injury or hereditary spastic paraparesis
• Aged 7 years and older
• Child is undergoing BoNT-A injections at the Kids Rehab Department at the Children’s Hospital at Westmead.
• Child is self-selecting to not have access to inhaled nitrous oxide, midazolam or general anaesthetic
• Having sufficient intellectual capacity and communicative ability to self-report and participate in the intervention – assessed through review of medical records where participant is reported as having no more than mild intellectual disability/delay and parent-report.
• Consent obtained from the parent/guardian and child.
• English language proficiency
• Access to a smart device (personal or department owned)
Minimum age
7 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• The child or parent require an interpreter
• The child has had previous biofeedback training
• The child has a severe visual impairment
• The procedure is being performed under general anesthetic, heavy sedation (e.g. midazolam, chloral hydrate) or under the administration of nitrous oxide
• The procedure needs to be conducted urgently

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into permuted blocks with stratification of age using computed generated randomisation software. Blocking will be stratified by age as this is considered to be an important prognostic factor that should be balanced between groups. The study will be stratified by the following age groups: 7-12 years (inclusive) and 13years and over
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The Faces Pain Scale – Revised (FPS-R) is the primary outcome measure. It consists of 6 gender neutral line drawings of faces and is scored on a 0-10 metric. In children undergoing medical treatment, a standard deviation of 2.9 between subjects in their scores was observed on the FPS-R. A change of 2 points on this scale represents a meaningful clinically significant difference .

Original power calculation suggested a sample of 46 patients to be recruited . This sample size gives 80% power at two-sided 5% alpha to detect a difference of 2 in the mean score between BrightHearts and Distraction therapy using a paired t-test and assuming a low correlation of 0.1 between scores within patient, and assuming 30% loss to follow-up. If the observed correlation within patients is higher, then the power will be more than 80%.

Following recruitment delays due to the coronavirus pandemic, a subsequent sample size analysis was conducted. This analysis indicated that recruitment and data collection ceasing upon 38 participants completing both intervention arms, with a drop-out rate of 21% would be sufficient to detect a meaningful clinically significant difference on the primary outcome measure. This revised sample size was subsequently applied.

The primary outcome for the analysis is self-reported pain experienced during a medical procedure. A series of t-tests will be conducted to analyse a treatment effect, carry-over effect and period effect. Similar analyses will be conducted on the secondary outcome measures of anxiety and fear.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/04/2018
Date of last participant enrolment
Anticipated
30/06/2020
Actual
20/10/2020
Date of last data collection
Anticipated
30/10/2020
Actual
14/04/2021
Sample size
Target
38
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15614 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 21076 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 29014 0
2145 - Westmead
Recruitment postcode(s) [2] 35929 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 304671 0
Charities/Societies/Foundations
Name [1] 304671 0
The Research Foundation, Cerebral Palsy Alliance
Country [1] 304671 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Cnr Hawkesbury Road and Hainsworth Street, Westmead, NSW Australia
Locked Bag 4001, Westmead 2145, NSW Australia
Country
Australia
Secondary sponsor category [1] 304993 0
None
Name [1] 304993 0
Address [1] 304993 0
Country [1] 304993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305091 0
Sydney Children's Hospital Network Human Research Ethics Commitee
Ethics committee address [1] 305091 0
Ethics committee country [1] 305091 0
Australia
Date submitted for ethics approval [1] 305091 0
Approval date [1] 305091 0
24/11/2017
Ethics approval number [1] 305091 0
HREC/17/SCHN/383

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

Contacts
Principal investigator
Name 99242 0
Dr Angela Morrow
Address 99242 0
Kids Rehab, the Children's Hospital at Westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead, NSW Australia
Locked Bag 4001, Westmead 2145, NSW Australia
Country 99242 0
Australia
Phone 99242 0
+61 0298456713
Fax 99242 0
Email 99242 0
angie.morrow@health.nsw.gov.au
Contact person for public queries
Name 99243 0
Katarina Ostojic
Address 99243 0
Kids Rehab, the Children's Hospital at Westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead, NSW Australia
Locked Bag 4001, Westmead 2145, NSW Australia
Country 99243 0
Australia
Phone 99243 0
+61 0298450267
Fax 99243 0
Email 99243 0
katarina.ostojic@health.nsw.gov.au
Contact person for scientific queries
Name 99244 0
Katarina Ostojic
Address 99244 0
Kids Rehab, the Children's Hospital at Westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead, NSW Australia
Locked Bag 4001, Westmead 2145, NSW Australia
Country 99244 0
Australia
Phone 99244 0
+61 0298450267
Fax 99244 0
Email 99244 0
katarina.ostojic@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
SourceTitleYear of PublicationDOI
EmbaseBiofeedback assisted relaxation training and distraction therapy for pain in children undergoing botulinum neurotoxin A injections: A crossover randomized controlled trial.2022https://dx.doi.org/10.1111/dmcn.15303
N.B. These documents automatically identified may not have been verified by the study sponsor.