Using sensory fidget toys to reduce anxiety in children before and after surgery
Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH)
This project will test whether giving sensory fidget toys before and after surgery helps reduce anxiety in children aged 5 to 15 having elective operations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 5 Years to 15 Years |
| Sex | All |
| Sponsor | Telethon Kids Institute Academic / other |
| Locations | 2 sites (Perth, Western Australia and 1 other locations) |
| Trial ID | NCT07270029 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls children aged 5 to 15 who are having elective day-case or one-night surgeries at Perth Children's Hospital or Hospital das Clínicas in São Paulo. Participants will receive a sensory fidget toy before and after their operation, and researchers will collect measures of preoperative anxiety, postoperative distress, pain, and recovery-related outcomes. Data will be compared across participants to see if the toy intervention reduces anxiety and downstream effects such as emergence delirium, increased pain medication use, and longer hospital stays. The protocol was developed with input from youth consumer partners and aims to offer a simple, low-cost coping tool to use alongside usual perioperative care.
Who should consider this trial
Good fit: Children aged 5 to 15.99 undergoing elective day-case or one-night surgeries at the participating hospitals who can safely interact with a sensory toy are ideal candidates.
Not a fit: Children who cannot safely use the sensory toy (for example, severe global developmental delay), those with language barriers that prevent data collection, or children admitted via other wards rather than the day-of-surgery unit may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this low-cost approach could lower children's pre- and post-surgical anxiety and reduce related problems like emergence delirium, higher pain, and longer hospital stays.
How similar studies have performed: Distraction and sensory-based approaches are commonly used and have shown benefit for perioperative anxiety, but formal trials specifically testing fidget or sensory toys are limited.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Perth, Western Australia and 1 other locations
- Perth Children's Hospital — Perth, Western Australia, Australia (Recruiting)
- Hospital das Clinicas — São Paulo, São Paulo, Brazil (Not_yet_recruiting)
Study contacts
- Study coordinator: Britta S von Ungern-Sternberg, MD, PhD
- Email: britta.regli-vonungern@health.wa.gov.au
- Phone: +61 8 6456 4806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.