Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH)

NCT07270029 | Recruiting DMC

• 1 other identifier: RGS0000007990
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 2

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.

Conditions

Perioperative Anxiety

Keywords

children; pediatrics; surgery; pediatric anaesthesia; anxiety; perioperative anxiety; fidget toys; sensory toys

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline anxiety will be assessed on the preoperative ward on the day of surgery (on pre-operative ward, T1), and at sign-in to theatre (when patient is moved from pre-operative ward to induction room, T2 ).

Secondary Outcomes (17)

• 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 assessed on the day of surgery in the perioperative holding area (T1, in pre-operative holding area), at sign-in to theatre (T2,when patient is moved from ward to induction room) and during induction (T3, when mask or needle is applied)

• Compare induction compliance between the sensory toy group and the control group on the day of surgery

  Assessed on the day of surgery during anaesthetic induction (application of the mask or the needle)

• Compare postoperative analgesia requirements between control group and sensory toy group

  Analgesics will be recorded until 24 hours post-surgery or time of discharge, whichever is sooner.

• Comparison of incidence of emergence delirium between sensory toy and control groups

  Emergence delirium will be assessed after surgery when the child wakes immediately after anaesthesia until discharge from the post-anaesthetic care unit (PACU) on the day of surgery.

• Compare post-operative behavioural outcomes between control group and sensory toy group

  Assessed on days 1 and 7 post-operatively

Study Arms (2)

Sensory toy group

EXPERIMENTAL

Children receive a sensory toy of their choice preoperatively

Other: Pre-operative sensory toy

Control group

SHAM COMPARATOR

Children receive a sensory toy at the time of discharge from hospital

Other: Post-operative sensory toy

Interventions

Pre-operative sensory toy OTHER

Sensory 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.

Also known as: Fidget toy, fidget device

Sensory toy group

Post-operative sensory toy OTHER

Sensory 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.

Also known as: fidget toy, fidget device

Control group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Telethon Kids Institute: lead
• University of Sao Paulo: collaborator
• Hospital das Clínicas de São Paulo - SP: collaborator
• Child and Adolescent Health Service - Perth: collaborator

Study Sites (2)

Perth Children's Hospital

Perth, Western Australia, 6009, Australia

RECRUITING

Hospital das Clinicas

São Paulo, São Paulo, Brazil

NOT YET RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Britta S von Ungern-Sternberg, MD, PhD

CONTACT

+61 8 6456 4806; britta.regli-vonungern@health.wa.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled multicentre trial

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 8, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); AU (1)