None listed
Conditions
Brief summary
This randomised controlled study will examine the impact of a 3D virtual reality (VR) intervention versus a two-dimensional (2D) video on pre-operative anxiety and induction compliance. .This study will provide evidence on the ongoing clinical use of 3D VR Goggles during the preoperative period at Perth Children's Hospital (PCH), to reduce anxiety and improve coping of children undergoing surgery. Given preoperative anxiety is so common amongst children, it is vital to find suitable strategies to control and reduce this anxiety in order to improve the overall patient experience. Children exposed to negative medical experiences may have a higher incidence of negative post-operative behavioural outcomes and often display increased fear and poor coping during subsequent medical procedures. By fostering a more positive and fun environment for children through the use of 3D VR goggles, there is potential to reduce negative post-operative outcomes and help children to recall their surgical journey as a more positive, exciting and non-threatening experience. Primary hypothesis: Children allocated to the 3D VR intervention group will display a significantly smaller increase in anxiety during anaesthetic induction from baseline, compared to the 2D video group Secondary hypotheses: 1. Children allocated to the 3D VR intervention group will display better induction compliance than children in the 2D video group 2. The 3D VR intervention will be more useful than the 2D intervention in helping the child cope with the induction process
Interventions
Patients undergoing general anaesthesia will be block randmonised in a 1:1 ratio to receive distraction either using the 3D virtual reality goggles(Smileyscope) or a 2D video during their anaesthetic induction. Randomisaton will be stratified by age (younger 4-8 years) and older (9-13 years). Children allocated to the virtual reality (VR) group will receive the 3D VR headset once they have entered the induction room and are seated on the bed. The goggles will be secured to the child’s head once
Patients undergoing general anaesthesia will be block randmonised in a 1:1 ratio to receive distraction either using the 3D virtual reality goggles(Smileyscope) or a 2D video during their anaesthetic induction. Randomisaton will be stratified by age (younger 4-8 years) and older (9-13 years). Children allocated to the virtual reality (VR) group will receive the 3D VR headset once they have entered the induction room and are seated on the bed. The goggles will be secured to the child’s head once they are comfortable, and the 5-minute breathing video of a relaxing underwater world option on the 3D VR goggles will be played. The anaesthetist is positioned beside the child in the anaesthetic induction room and therefore will be able to monitor the adherence to the intervention. The anaesthetist will also be able to hear the video playing while in use. The headset will be worn until the anaesthetist deems the child to be sufficiently anaesthetised. After each use, the 3D VR headset will be removed, and sanitised as per institutional guidelines and recharged. For those children having a gas induction, the method of gas delivery will be left to the anaesthetist’s discretion (turning mask upside down etc.) The virtual reality headsets will be sourced from Smileyscope Pty ltd (Smileyscope Pty Ltd, Melbourne, Australia, VIC300), a leading healthcare technology company. The goggles consist of a headband and headset attached to a smart phone device.
Sponsors
Child & Adolescent Health Service Executive at Perth Children's Hopsital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
Children aged 4- 13 years of age undergoing elective or emergency surgery at Perth Children's Hospital
Exclusion criteria
Any visual, auditory, or cognitive impairments preventing interaction with the VR intervention, particularly a history of epilepsy or seizures Any critical medical condition or condition that precludes the use of VR Methicillin resistant Staphylococcus aureus infection or symptoms of respiratory or gastrointestinal infection that may contaminate VR equipment. VR equipment and the iPad will be cleaned with standard equipment cleaning policies aligned with all theatre equipment. Children receiving midazolam or ketamine as a premedication VR headset does not fit patient at the researchers discretion Any concern in the ability of the parents/guardian or child to appropriately adhere to the study protocol or any issues which, in the investigator’s opinion, would increase the risks of study participation to the child. Language barriers impeding data collection Department for child Protection and Family Support is involved in their care
Outcome results
None listed