Anxiety associated with medical procedures is common, with 40-80% of children experiencing significant symptoms and postoperative consequences, including distress and delirium, increased intensity/duration of pain, prolonged hospital stays, behavioural/sleep disturbance and avoidance of medical encounters, which often remain into adulthood.
Extensive consumer research has shown that a key priority for Australian consumers of all ages in relation to paediatric hospital care is addressing the fear and anxiety in children throughout the hospital experience (second only to anaesthesia safety for adults and third following anaesthesia safety and pain management for children).
The STARFISH trial was driven by our consumer partners, particularly our youth consumers. It is well known that distraction is a coping strategy that can help with perioperative anxiety, and all members of the perioperative team commonly employ distraction techniques with patients during routine clinical care. One potential form of distraction involves sensory activities - fidget devices or sensory toys such as spinners, putty, and stability balls are increasingly being used within school settings to help students academically and behaviourally, with applicability for neurodiverse (e.g., autistic, Attention Deficit Hyperactivity Disorder (ADHD)) children being one area of particular interest. However, the research behind sensory toys is inconclusive.
Sensory toys have been suggested to our team-from numerous consumers of all ages, including neurodiverse and neurotypical consumers-as a method to reduce anxiety in the preoperative period, thus leading to the design of the STARFISH trial.
This project aims to assess the use of a sensory toy (of the child's choice) in the perioperative period on the day of surgery to reduce perioperative anxiety and distress.
Children aged 5-15.99 years of age
Children admitted to the day of surgery unit undergoing elective surgery at Perth Children's Hospital or Hospital das Clinicas HCFMUSP as day case surgeries or with a maximum hospital stay of one night postoperatively
Children coming for surgery via wards other than the day of surgery unit
Language barriers impeding data collection
Department for Child Protection and Family Support is involved in the care of the child
Inability for the child to interact with the sensory toy safely, such as children with severe global developmental delay (GDD).
Parallel
Pre-operative sensory toy
Other interventionSensory toy (e.g., spinners, putty, stability balls) chosen by the child on the day of surgery pre-operatively. All sensory toys will be sourced from Australian company for Perth Children's Hospital and from a Brazilian company for Hospital das Clinicas HCFMUSP.
Post-operative sensory toy
Other interventionSensory toy (e.g., spinners, putty, stability balls) chosen by the child upon discharge from hospital following their surgery. All sensory toys will be sourced from Australian company for Perth Children's Hospital and from a Brazilian company for Hospital das Clinicas HCFMUSP.
Compare anxiety levels on day of surgery at sign-in to theatre (T2, when patient is moved from pre-operative ward to induction room) and baseline (T1, on pre-operative ward ) between children in sensory toy group and those in the control group.
Anxiety will be measured using the modified Yale Perioperative Anxiety Scale (mYPAS). mYPAS consists of 22 items in 5 categories: activity (4 items), vocalisations (6 items), emotional expressivity (4 items), state of apparent arousal (4 items) and use of parents (4 items). The highest observed behavioural item in each category is the score for that category. The minimum score at each timepoint is 5 and the maximum score is 22. High mYPAS scores at each time point are indicative of higher preoperative anxiety.
Compare anxiety levels at baseline, sign in to theatre, and at induction of anaesthesia on the day of surgery between the sensory toy group and control group
Anxiety will be measured using the modified Yale Perioperative Anxiety Scale (mYPAS). mYPAS consists of 22 items in 5 categories: activity (4 items), vocalisations (6 items), emotional expressivity (4 items), state of apparent arousal (4 items) and use of parents (4 items). The highest observed behavioural item in each category is the score for that category. The minimum score at each timepoint is 5 and the maximum score is 22. High mYPAS scores at each time point are indicative of higher preoperative anxiety.
Compare induction compliance between the sensory toy group and the control group on the day of surgery
Induction compliance will be assessed using the induction compliance checklist (ICC). The ICC contains 11 items, giving a score from 0 (extremely compliant) to 11 (extremely uncompliant).
Compare postoperative analgesia requirements between control group and sensory toy group
All post-operative analgesics (paracetamol, NSAIDs, opioids) given post-operatively will be recorded
Comparison of incidence of emergence delirium between sensory toy and control groups
Emergence delirium will be assessed by the post-operative recovery nurse using the WATCHA scale. The WATCHA scale is scored from 0 (asleep) to 4 (agitated, thrashing around) , scores greater than or equal to 3 on this scale are indicative of emergence delirium.
Click on the lead sponsor to view all of their trials.
Telethon Kids Institute
Lead sponsor
Child and Adolescent Health Service - Perth
Collaborator
University of Sao Paulo
Collaborator
Hospital das Clínicas de São Paulo - SP
Collaborator
