[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613702":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":41,"responsibleParty":78,"collaborators":80,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":34,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":44,"whyStopped":34,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Telethon Kids Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sensory toy group","EXPERIMENTAL","Children receive a sensory toy of their choice preoperatively",[13],"Other: Pre-operative sensory toy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","Children receive a sensory toy at the time of discharge from hospital",[19],"Other: Post-operative sensory toy",[21,28],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],[26,27],"Fidget toy","fidget device",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"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.",[15],[33,27],"fidget toy",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Britta S von Ungern-Sternberg, MD, PhD","CONTACT","+61 8 6456 4806","britta.regli-vonungern@health.wa.gov.au",[42,62],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Perth Children's Hospital","RECRUITING","Perth","Western Australia","6009","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],115.8614,-31.95224,{"lat":54,"lon":53},[57,58],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},{"name":59,"role":38,"phone":60,"phoneExt":34,"email":61},"Lliana Slevin, BSC","+61 426 952 977","lliana.slevin@thekids.org.au",{"facility":63,"status":64,"city":65,"state":65,"zip":34,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Hospital das Clinicas","NOT_YET_RECRUITING","São Paulo","Brazil","BR",{"type":51,"coordinates":69},[70,71],-46.63611,-23.5475,{"lat":71,"lon":70},[74],{"name":75,"role":38,"phone":76,"phoneExt":34,"email":77},"Vinícius Quintão, MD, PhD","+55 11 2661 5795","vinicius.quintao@hc.fm.usp.br",{"type":79,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[81,84,86],{"name":82,"class":83},"Child and Adolescent Health Service - Perth","OTHER_GOV",{"name":85,"class":6},"University of Sao Paulo",{"name":87,"class":88},"Hospital das Clínicas de São Paulo - SP","UNKNOWN","100613702","sensory-toys-for-anxiety-reduction---can-fidget-toys-improve-stress-and-help-children-to-cope-before-surgery-starfish-100613702",false,"NCT07270029","Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH)","STARFISH","Inclusion Criteria:\n\n* Children aged 5-15.99 years of age\n* 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\n\nExclusion Criteria:\n\n* Children coming for surgery via wards other than the day of surgery unit\n* Language barriers impeding data collection\n* Department for Child Protection and Family Support is involved in the care of the child\n* Inability for the child to interact with the sensory toy safely, such as children with severe global developmental delay (GDD).","ALL","5 Years","15 Years",{"count":100,"type":101},500,"ESTIMATED","INTERVENTIONAL",[104],"NA","Anxiety associated with medical procedures is common, with 40-80% of children experiencing significant symptoms and postoperative consequences, including distress and delirium, increased intensity\u002Fduration of pain, prolonged hospital stays, behavioural\u002Fsleep disturbance and avoidance of medical encounters, which often remain into adulthood.\n\nExtensive 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).\n\nThe 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.\n\nSensory 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.\n\nThis 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.",[107],"Perioperative Anxiety",[109,110,111,112,113,114,115,116],"children","pediatrics","surgery","pediatric anaesthesia","anxiety","perioperative anxiety","fidget toys","sensory toys","2026-03-23",{"date":119,"type":120},"2026-03-24","ACTUAL",{"date":122,"type":120},"2026-01-08",{"date":124,"type":101},"2028-12-30",{"name":5,"class":6},2]