None listed
Conditions
Brief summary
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.
Interventions
This study is a randomised controlled multicentre trial.
Following voluntary informed consent by the parent/guardian and assent by the child, recruited children will be randomised in a 1: 1 ratio to receive a sensory toy of their choice preoperatively (experimental group) or at the time of discharge (control group). All sensory toys will be sourced from a reputable Australian company for Perth Children's Hospital and from a Brazilian company for Hospital das Clinicas HCFMUSP.
Patients in the
This study is a randomised controlled multicentre trial. Following voluntary informed consent by the parent/guardian and assent by the child, recruited children will be randomised in a 1: 1 ratio to receive a sensory toy of their choice preoperatively (experimental group) or at the time of discharge (control group). All sensory toys will be sourced from a reputable Australian company for Perth Children's Hospital and from a Brazilian company for Hospital das Clinicas HCFMUSP. Patients in the experimental group will receive a sensory toy of their choice shortly after admission to the pre-operative ward. Patients in this group will receive their sensory toy once enrolled in the study while waiting in the pre-operative ward (approximately 2 hours before their planned anaesthetic induction time), during their anaesthetic induction and recovery, and will be allowed to keep the toy after discharge from hospital. A range of sensory toys have been selected for the study from our consumers comprising of children, young adults and adults who reviewed a wide range availble on the Australian market. These sensory toys or tools will include a selection of fidgets including squishy balls/cubes, squisky tubes, hard and soft fidgets and hand figets. Use of sensory toy in pre-op will be rated on a 5-point likert scale and the effectiveness of the toy in pre-op will be rated on a 5-point likert scale by the parent and clinical staff. Use and effectiveness of the toy in induction will be recorded by the treating anaesthetist upon visual review of patient.
Sponsors
The Kids Research Institute Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Children admitted to the day of surgery unit undergoing elective surgery at Perth Children's Hospital as day case surgeries or with a maximum hospital stay of one night post-operatively
Exclusion criteria
- 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).
Outcome results
None listed