Perioperative AnxietySTARFISHNCT07270029
Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH)
A study testing Pre-operative sensory toy and Post-operative sensory toy in people with Perioperative Anxiety, run by Telethon Kids Institute at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Perioperative Anxiety
- What is being tested?
- Pre-operative sensory toy and Post-operative sensory toy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Jan 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Britta S von Ungern-Sternberg, MD, PhD contact
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
Perth Children's Hospital
Perth, Western Australia, 6009
Britta S von Ungern-Sternberg, MD, PhD, +61 8 6456 4806, britta.regli-vonungern@health.wa.gov.au
Lliana Slevin, BSC, +61 426 952 977, lliana.slevin@thekids.org.au
Brazil1 site, 1 recruiting
- Not yet recruiting
Hospital das Clinicas
São Paulo, São Paulo
Vinícius Quintão, MD, PhD, +55 11 2661 5795, vinicius.quintao@hc.fm.usp.br
About this study
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).
Read more
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.
Read the 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
- Being tested
- Pre-operative sensory toy, Post-operative sensory toy
- Keywords
- children, pediatrics, surgery, pediatric anaesthesia, anxiety, perioperative anxiety, fidget toys, sensory toys
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative sensory toyOther
Also called Fidget toy, fidget device
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.
Post-operative sensory toyOther
Also called fidget toy, fidget device
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.
| Study group | Role | What they receive |
|---|---|---|
| Sensory toy group | Experimental | Children receive a sensory toy of their choice preoperatively Receives: Other: Pre-operative sensory toy |
| Control group | Sham comparator | Children receive a sensory toy at the time of discharge from hospital Receives: Other: Post-operative sensory toy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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
Induction compliance will be assessed using the induction compliance checklist (ICC). The ICC contains 11 items, giving a score from 0 (extremely compliant) to 11 (extremely uncompliant).
Measured: 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
All post-operative analgesics (paracetamol, NSAIDs, opioids) given post-operatively will be recorded
Measured: 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 by the post-operative recovery nurse using the WATCHA scale. The WATCHA scale is scored from 0 (asleep) to 4 (agitated, thrashing around) , scores greater than or equal to 3 on this scale are indicative of emergence delirium.
Measured: 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 using the Post-Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS). The PHBQ-AS consists of 11 questions regarding a patient's behaviour and is answered using a 5-point likert scale (much less than before, less than before, same as before, more than before, much more than before).
Measured: Assessed on days 1 and 7 post-operatively
Assessment of the parental and child satisfaction with the intervention
Assessed on a 5-point Likert scale
Measured: Assessed on the day of surgery at sign-out to theatre (patient moved from ward to induction room) or prior to the administration of a sedative premedication; on the post-operative ward before hospital discharge, and at 7 days post-discharge
Compare differences in anxiety, induction compliance, post-operative analgesia requirements, emergence delirium and post-operative behavioural outcomes between neurodiverse and neurotypical children
Neurodiversity will be assessed via parent report of whether the child has a formal diagnosis of autism and/or ADHD, as well as parent completion of a brief item set based on DSM-5-TR criteria for autism and the Strength and Difficulties Questionnaire measure of ADHD in childhood as well as the Perth Autism Scale.
Measured: Neurodiversity will be assessed by a researcher via a questionnaire administered prior to surgery.
Compare incidence of emergence delirium between patients in the sensory toy group and control group
Emergence delirium will be assessed by the post-operative recovery nurse using the Pediatric Anaesthesia Emergence Delirium (PAED) scale in the post anaesthetic care unit (PACU). The PAED scale consists of 5 items and is scored on a 5 point scale (not at all, just a little, quite a bit, very much, extremely). higher scores are indicative of emergence delirium, the maximum score is 20 and minimum score is 0.
Measured: 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 incidence of perioperative respiratory adverse events (PRAE) and post-operative nausea and vomiting (PONV) between neurodiverse and neurotypical children
Perioperative respiratory adverse events (PRAE) are defined as: Major PRAE: laryngospasm or bronchospasm (as determined by the anaesthetist or recovery nurse) or desaturation <85% SpO2 for more than 1 minute on pulse oximetry. Minor PRAE: desaturation (<95% SpO2 for more than 10 seconds on pulse oximetry), airway obstruction, severe coughing, post-operative stridor. Each individual PRAE (laryngospasm, bronchospasm, desaturation, airway obstruction, severe persistent coughing and post-operative stridor) will be considered separately. PONV will be assessed by observing any incidence of nausea or vomiting post-operatively, and any administration of antiemetic medication.
Measured: PRAE will be assessed by the anaesthetist during anaesthetic induction, maintenance and emergence and by the recovery nurse while in the post-anaesthetic care unit (PACU). PONV will be assessed from waking in PACU until 24 hours post-surgery or discharge
Compare the post-operative behavioural outcomes between patients in the sensory toy group and control group using the Paediatric Scale for Quality of Recovery (PedSQoR).
post-operative behavioural outcomes will be measured using the Paediatric Scale for Quality of Recovery (PedSQoR). The PedsQoR is made of 20 questions, the overall score ranges from 20 to 100 and higher scores indicate a better quality of recovery or more complete recovery.
Measured: Assessed 1 day and 7 days post- surgery
Compare anxiety levels a baseline, sign in to theatre and at induction of anaesthesia on the day of surgery between neurodiverse and neurotypical children
Anxiety will be measured using the modified Yale Perioperative Anxiety Scale. 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.
Measured: Anxiety will be assessed on the day of surgery in the perioperative holding area (T1, in pre-opeative ward), 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 on the day of surgery between neurodiverse and neurotypical children
Induction compliance will be assessed using the induction compliance checklist (ICC). The ICC contains 11 items, giving a score from 0 (extremely compliant) to 11 (extremely uncompliant).
Measured: Assessed on the day of surgery during anaesthetic induction
Compare post-operative analgesia requirements between neurodiverse and neurotypical children
All post-operative analgesics (paracetamol, NSAIDS, opioids) given post-operatively will be recorded.
Measured: Analgesics will be recorded until 24 hours post-surgery or time of discharge from hospital
Compare incidence of emergence delirium between neurodiverse and neurotypical children
Emergence delirium will be assessed by the post-operative recovery nurse using the WATCHA Scale. The WATCHA Scale is scored from 0 (asleep) to 4 (thrashing around). Scores greater than or equal to 2 on this scale are indicative of emergence delirium.
Measured: 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 incidence of emergence delirium between neurodiverse and neurotypical children
Emergence delirium will be assessed by the post-operative recovery nurse using the Pediatric Anaesthesia Emergence Delirium (PAED) scale in the post anaesthetic care unit (PACU). The PAED scale consists of 5 items and is scored on a 5 point scale (not at all, just a little, quite a bit, very much, extremely). higher scores are indicative of emergence delirium, the maximum score is 20 and minimum score is 0.
Measured: 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 neurodiverse and neurotypical children
Assessed using the Post-Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS). The PHBQ-AS consists of 11 questions regarding a patient's behaviour and is answered using a 5-point likert scale (much less than before, less than before, same as before, more than before, much more than before).
Measured: Assessed on days 1 and 7 post-operatively
Compare the post-operative behavioural outcomes between neurodiverse and neurotypical children using the Paediatric Scale for Quality of Recovery (PedSQoR).
post-operative behavioural outcomes will be measured using the Paediatric Scale for Quality of Recovery (PedSQoR). The PedsQoR is made of 20 questions, the overall score ranges from 20 to 100 and higher scores indicate a better quality of recovery or more complete recovery.
Measured: Assessed 1 day and 7 days post- surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start8 Jan 2026
- Primary completion15 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled multicentre trial
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telethon Kids Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Child and Adolescent Health Service - Perth, University of Sao Paulo, University of Sao Paulo General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270029
- Sponsor's protocol ID
- RGS0000007990
- Acronym
- STARFISH
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH)
- ClinicalTrials.gov ID
- NCT07270029
- Acronym / sponsor ID
- STARFISH / RGS0000007990
- Conditions
- Perioperative Anxiety
- Keywords
- children, pediatrics, surgery, pediatric anaesthesia, anxiety, perioperative anxiety, fidget toys, sensory toys
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Telethon Kids InstituteUniversity, hospital or other
- Collaborators
- Child and Adolescent Health Service - Perth, University of Sao Paulo, University of Sao Paulo General Hospital
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled multicentre trial
| Arm | Type | Receives |
|---|---|---|
| Sensory toy group | Experimental | Other: Pre-operative sensory toyChildren receive a sensory toy of their choice preoperatively |
| Control group | Sham comparator | Other: Post-operative sensory toyChildren receive a sensory toy at the time of discharge from hospital |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative sensory toyAlso: Fidget toy, fidget deviceSensory 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. | Other | Sensory toy group |
| Post-operative sensory toyAlso: fidget toy, fidget deviceSensory 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. | Other | Control group |
Primary outcome
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.
Time frame: 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 ).
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.
17 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessed on days 1 and 7 post-operatively
Assessment of the parental and child satisfaction with the intervention
Time frame: Assessed on the day of surgery at sign-out to theatre (patient moved from ward to induction room) or prior to the administration of a sedative premedication; on the post-operative ward before hospital discharge, and at 7 days post-discharge
Compare differences in anxiety, induction compliance, post-operative analgesia requirements, emergence delirium and post-operative behavioural outcomes between neurodiverse and neurotypical children
Time frame: Neurodiversity will be assessed by a researcher via a questionnaire administered prior to surgery.
Compare incidence of emergence delirium between patients in the sensory toy group and control group
Time frame: 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 incidence of perioperative respiratory adverse events (PRAE) and post-operative nausea and vomiting (PONV) between neurodiverse and neurotypical children
Time frame: PRAE will be assessed by the anaesthetist during anaesthetic induction, maintenance and emergence and by the recovery nurse while in the post-anaesthetic care unit (PACU). PONV will be assessed from waking in PACU until 24 hours post-surgery or discharge
Compare the post-operative behavioural outcomes between patients in the sensory toy group and control group using the Paediatric Scale for Quality of Recovery (PedSQoR).
Time frame: Assessed 1 day and 7 days post- surgery
Compare anxiety levels a baseline, sign in to theatre and at induction of anaesthesia on the day of surgery between neurodiverse and neurotypical children
Time frame: Anxiety will be assessed on the day of surgery in the perioperative holding area (T1, in pre-opeative ward), 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 on the day of surgery between neurodiverse and neurotypical children
Time frame: Assessed on the day of surgery during anaesthetic induction
Compare post-operative analgesia requirements between neurodiverse and neurotypical children
Time frame: Analgesics will be recorded until 24 hours post-surgery or time of discharge from hospital
Compare incidence of emergence delirium between neurodiverse and neurotypical children
Time frame: 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 incidence of emergence delirium between neurodiverse and neurotypical children
Time frame: 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 neurodiverse and neurotypical children
Time frame: Assessed on days 1 and 7 post-operatively
Compare the post-operative behavioural outcomes between neurodiverse and neurotypical children using the Paediatric Scale for Quality of Recovery (PedSQoR).
Time frame: Assessed 1 day and 7 days post- surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Britta S von Ungern-Sternberg, MD, PhD contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative sensory toy and Post-operative sensory toy in people with Perioperative Anxiety, run by Telethon Kids Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Britta S von Ungern-Sternberg, MD, PhD (+61 8 6456 4806, britta.regli-vonungern@health.wa.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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 ).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.