Biofeedback assisted relaxation training for the management of pain in children with physical disabilities undergoing lower limb orthopaedic surgery

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.