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

NCT ID: NCT07270029

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2028-12-30

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.

Detailed Description

Anxiety associated with hospital experiences is common and a key concern for families and clinicians. Anxiety is linked to a number of adverse outcomes in children, including an increased risk of emergence delirium after anaesthesia, increased/prolonged pain, increased medication use (particularly strong pain killers, sedating agents), prolonged hospital stay, negative post-procedural behavioural outcomes, distress to children, families and medical staff, as well as distress to other children and families who witness a child in distress. Furthermore, anxiety can lead to long-term avoidance of healthcare encounters and consequently to negative health outcomes which can be life-long. This avoidance can impact not only the child's health care trajectory but also the health-trajectory and wellbeing of their parents and siblings.

In many institutions, including Perth Children's Hospital (PCH), pharmacological interventions in the form of sedative pre-medication are currently the most common strategy used to manage preoperative anxiety. Midazolam, for example, is a pre-medication widely used to reduce preoperative anxiety. Various studies have displayed the efficacy of midazolam in improving child behaviour during induction and reducing anxiety. Pharmacological interventions, however, have limitations, including the requirement to monitor patients after drug administration for potential adverse side effects and changes in vital signs. This increases staff requirements, placing more pressure on nurses and driving costs upwards. Paediatric patients may even find the process of taking pre-medication more traumatising than the hospital experience itself. Furthermore, while children may seem less anxious during the induction of anaesthesia following premedication with midazolam, research suggests that midazolam can paradoxically increase the incidence of post-hospital behavioural change. Some patients describe feeling anxious inside and "locked in", while from the outside looking calm, increasing their perceived anxiety even more. Additionally, pre-medication does not address the cause of the anxiety or help to develop strategies that may improve a child's ability to cope with stressful circumstances into the future.

A promising strategy that can reduce intense anxiety is distraction, and it has long been recognised that distraction leads to a significant reduction in perioperative anxiety. Distraction can take many forms, and while it is an under-researched area, there is a high potential for involving distraction via sensory experiences.

In this context, the use of sensory toys (e.g., spinners, putty, and stability balls) has been repeatedly suggested by consumers of all ages to aid with anxiety management. The benefit of sensory toys is that they can be used by nearly all children of a certain age group, including many who are neurodiverse, have special needs, and children from diverse cultural backgrounds, languages other than English, and those in regional/remote areas. Previous attempts at delivering tools for children to self-manage symptoms of anxiety have been labour-intensive to implement and train. Although purchasing the sensory toy incurs a cost, it remains a relatively inexpensive intervention that, could be easily implemented to benefit the child beyond the hospital experience. The costs are likely offset by a reduced requirement for premedication and thus a lower requirement for close nursing observation levels and time savings due to fewer theatre delays caused by incorrect timing of premedications.

This randomised controlled multicentre trial will assess the effect of a sensory toy on the child's preoperative anxiety, administered on the day of surgery. It will further assess, the cost of the intervention, the impact on anaesthesia induction, premedication as well as immediate and short term (1 week) outcomes for children undergoing surgery or procedures under general anaesthesia.

Conditions

Perioperative Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sensory toy group

Children receive a sensory toy of their choice preoperatively

Group Type: EXPERIMENTAL

Pre-operative sensory toy

Intervention Type: 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.

Control group

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

Group Type: SHAM_COMPARATOR

Post-operative sensory toy

Intervention Type: 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.

Interventions

Pre-operative sensory toy

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.

Intervention Type: OTHER

Post-operative sensory toy

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.

Intervention Type: OTHER

Other Intervention Names

Fidget toy; fidget device; fidget toy; fidget device

Eligibility Criteria

Inclusion Criteria

• 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

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).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Child and Adolescent Health Service - Perth

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Hospital das Clínicas de São Paulo - SP

UNKNOWN

Sponsor Role: collaborator

Telethon Kids Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Perth Children's Hospital

Perth, Western Australia, Australia

Hospital das Clinicas

São Paulo, São Paulo, Brazil

Countries

Australia; Brazil

Central Contacts

Britta S von Ungern-Sternberg, MD, PhD

Role: CONTACT

britta.regli-vonungern@health.wa.gov.au

+61 8 6456 4806

Facility Contacts

Britta S von Ungern-Sternberg, MD, PhD

Role: primary

britta.regli-vonungern@health.wa.gov.au

+61 8 6456 4806

Lliana Slevin, BSC

Role: backup

lliana.slevin@thekids.org.au

+61 426 952 977

Vinícius Quintão, MD, PhD

Role: primary

vinicius.quintao@hc.fm.usp.br

+55 11 2661 5795

Other Identifiers

RGS0000007990

Identifier Type: -

Identifier Source: org_study_id