BrightHearts RCT: procedural pain management during botulinum toxin-A injections.

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.