Actively Recruiting

Phase Not Applicable
Age: 5Years - 15Years
All Genders
NCT07270029

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

Age: 5Years - 15Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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