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Open Access Study protocol

Improving access to preparatory information for children undergoing general anaesthesia for tooth extraction and their families: study protocol for a Phase III randomized controlled trial

Marie Therese Hosey1*, Ana Nora Donaldson1, Corinne Huntington1, Christina Liossi2, Patricia A Reynolds1, Reham Alharatani1 and J Timothy Newton1

Author Affiliations

1 King’s College London Dental Institute, Bessemer Road, London SE5 9RS, UK

2 Department of Psychology, University of Southampton, Building 44 Highfield Campus, Southampton SO17 1BJ, UK

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Trials 2014, 15:219  doi:10.1186/1745-6215-15-219

Published: 11 June 2014

Abstract

Background

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. 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/design

The 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.

Discussion

This study aims to determine the effectiveness of an online GA-coping game for children and families undergoing tooth extraction under GA.

Trial registration

ISRCTN18265148 (registered 24 November 2013).

Keywords:
General anaesthesia; Children; Preparatory information; Coping; Cognitive behavioural therapy; Role modelling; Early childhood caries; Dental anxiety; Randomized controlled trial (RCT)