Title: Evaluating the Little Journey app- An RCT of a virtual reality preparatory tool for children undergoing surgery with general anaesthesia
Funder: Department of Health and Social Care

Abstract: BACKGROUND Peri-operative anxiety affects a substantial proportion of children undergoing surgery [10]. Its direct link with worsened post-operative outcomes, emergence delirium and post-hospital behavioural changes means it is frequently studied. Interventions such as toys, books and hand-held tablets, focus around lowering of anxiety through distraction techniques in the anaesthetic room. Pharmacological interventions, while sometimes effective, may be associated with a paradoxical reaction, delayed hospital disharge and longer term adverse behavioural changes. A reduction in paediatric peri-operative anxiety through pre-operative education, has been shown in studies assessing interventions such as hospital tours and play therapy [11]; however, while such face-to-face interventions have been shown to be beneficial, they are not standard practice due to cost and time pressures [12]. Within healthcare, the use of virtual reality - computer generated, three-dimensional, imaginary environments with which a person can subjectively interact - is expanding. Studies have shown its effectiveness as a distraction tool for burns dressing changes and burns physiotherapy rehabilitation, leading to improvements in overall functional outcomes [13]. Therefore, we have developed Little Journey, a free smartphone app, to be used with a low-cost cardboard virtual reality headset, with the aim that this will be a low-cost and engaging technique to prepare children for ambulatory surgery. Through virtual reality, children can explore and familiarise themselves with the different areas, equipment and staff they will see during their hospital visit, while still at home before admission. As Little Journey is an interactive app which uses head tracking technology, children are able to control the pace of their learning and progression. AIM: To evaluate the clinical effectiveness of the Little Journey at reducing pre-operative anxiety in children, and secondary outcomes including longer-term behavioural change, parental satisfaction and parental anxiety. METHODS: We plan to perform a multi-centre, prospective, assessor blinded, randomised controlled trial evaluating the effectiveness of the Little Journey app at lowering pre-operative anxiety in comparison to standard practice. 304 children, aged 3-12 years of age, undergoing general anaesthesia for planned dental surgery will be randomised either to receive the Little Journey app for use at home for at least 2 weeks before surgery (in addition to standard pre- and perioperative care), or standard care only. Our primary outcome measure is the modified Yale Pre-operative Anxiety Score short-form (m-YPAS-SF). This is a validated observation tool developed to measure peri-operative anxiety levels, which will be recorded by an independent observer, blinded to the treatment arm. It will be measured during the induction of anaesthesia, and adjusted in analysis for baseline (pre-randomisation preoperative assessment clinic) anxiety levels using an ANCOVA analysis. Secondary outcomes include parental anxiety, post-operative negative behavioural changes at two-weeks after surgery, parental satisfaction and compliance during induction. In-app analytics will enable analysis of the timing and frequency of the Little Journey app use. POTENTIAL BENEFITS: We hypothesize that use of the Little Journey app will lower pre-operative patient anxiety levels, as well as reduce the frequency of post-hospital behavioural changes and improve parental anxiety and satisfaction. Working as part of a multimodal tailored approach to anxiety management, this new non-pharmacological preparatory intervention may improve patient and parent hospital experience, while reducing anxiety related complications. The technology is low-cost and rapidly adoptable and therefore, if found to be beneficial, it could be widely introduced into practice, leading to patient and service benefit, within a short timeframe of the study results being disseminated. Our study team consists of patient representation, clinical and academic experts in anaesthesia, surgery and clinical trials, and professional leaders who will help disseminate our findings effectively.

Lay abstract: Over half a million children have general anaesthesia (go to sleep) for an operation in the UK each year. Around three-quarters of these children become distressed or anxious before they go to sleep, and this is linked with later problems such as difficulty sleeping, nightmares and bedwetting. Medicines and other treatments to calm children may either cause other problems or are very expensive. To try to solve these problems, we have developed a virtual reality (VR) app, to prepare children for going to hospital and their operation. VR games are increasingly common. A well-known example is Pokemon Go. Our app is used on smartphones, with a disposable cardboard headset which we provide free. It enables children to meet cartoon characters of doctors and nurses, who show them what the inside of the hospital looks like, the people they will meet, and the equipment they will see. Our research will find out whether using the app reduces anxiety in 3 to 12-year-old children and their parents. We will contact the parents of children who are due to have surgery whilst asleep. 304 children will take part in the research. Half will be given our headset and VR app to use at home for at least two weeks before their surgery. The other half will be given only the headset which they can use for fun or with other openly available VR apps. We will measure how anxious children and parents are, before and up to 4 weeks after surgery. By comparing the level of anxiety between children who do and do not have access to the app, we will be able to tell whether or not it works. If we find that our app reduces anxiety, we will be able to quickly and cheaply spread this technology across the NHS.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH;ORAL AND GASTROINTESTINAL