Abstract
BackgroundChildren can find anaesthesia induction especially distressing and postoperative psychological and physical morbidity are common. Preparation programmes for general anaesthesia (GA) are highly effective in reducing this distress. A Phase II study has already verified the effectiveness of a prototype preoperative GA-coping computer game to help children cope with induction in a dental GA setting. The biggest patient users of pediatric GA services in the UK are children who need to have teeth removed (estimated to be 100,000 yearly). Tooth decay is the most common disease in children worldwide. This study is a Phase III randomized controlled trial (RCT) and will evaluate the effectiveness of the new internet version of this game.Methods/designThe Phase III RCT will use a double-blind three-armed design. The clinical trial will recruit up to 210 children and will compare the web-based game against standard care and another non-medical game. At least 53 patients in each group will be required for 90% statistical power. Distress will be assessed through an evaluation of the child’s behaviour during the visit and later parental reports of physical and psychological morbidity. The satisfaction of parents and children will be measured; the mode of usage of the web-based game will be automatically recorded and the impact on the service (for example, recovery time and throughput) will be reported.The Phase III study primary outcome will measure: (1) patient experience: acceptance of anaesthetic induction, child cooperation and distress, reduction of peri- and postoperative morbidity, child and family satisfaction, and (2) service improvement: anaesthetic time and improvement in throughput. Measures will be administered at baseline, at the time of the GA treatment visit, and at 48 hours and one week postoperatively.DiscussionThis study aims to determine the effectiveness of an online GA-coping game for children and families undergoing tooth extraction under GA.Trial registrationISRCTN18265148 (registered 24 November 2013).
Highlights
Children can find anaesthesia induction especially distressing and postoperative psychological and physical morbidity are common
This study aims to determine the effectiveness of an online general anaesthesia (GA)-coping game for children and families undergoing tooth extraction under GA
The aim of this paper is to present the methodology of a Phase III randomized controlled trial (RCT) to test the efficacy of an updated version of the prototype, available online at home, to facilitate coping in 5 to 7-year-old children undergoing GA for dental extractions
Summary
Children can find anaesthesia induction especially distressing and postoperative psychological and physical morbidity are common. Preparation programmes for general anaesthesia (GA) are highly effective in reducing this distress. A Phase II study has already verified the effectiveness of a prototype preoperative GA-coping computer game to help children cope with induction in a dental GA setting. This study is a Phase III randomized controlled trial (RCT) and will evaluate the effectiveness of the new internet version of this game. Psychological preparation of children beforehand has been shown to be highly effective in reducing distress and postoperative complications [8]. The use of computers and web-based psychological intervention is a growing area of interest with the notable advantages of accessibility and engagement at the individual’s own pace [10]. Our previous patient and public involvement work confirmed that over 70% of these families had computer access and internet capability to enable software such as ‘YouTube’ and they indicated that they would welcome this type of intervention
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