Actively Recruiting
Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH)
Led by Telethon Kids Institute · Updated on 2026-03-24
500
Participants Needed
2
Research Sites
155 weeks
Total Duration
On this page
Sponsors
T
Telethon Kids Institute
Lead Sponsor
C
Child and Adolescent Health Service - Perth
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 15.99 years
- Children admitted to the day of surgery unit
- Undergoing elective surgery at Perth Children's Hospital or Hospital das Clinicas HCFMUSP
- Surgery planned as day case or with maximum one night hospital stay postoperatively
You will not qualify if you...
- Children admitted for surgery through wards other than the day of surgery unit
- Language barriers that prevent data collection
- Department for Child Protection and Family Support involved in child's care
- Children unable to safely interact with sensory toys, such as those with severe global developmental delay
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Perth Children's Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
2
Hospital das Clinicas
São Paulo, São Paulo, Brazil
Not Yet Recruiting
Research Team
B
Britta S von Ungern-Sternberg, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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