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

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).

How families prepare their children for tooth extraction under general anaesthesia: Family and clinical predictors of non‐compliance with a ‘serious game’

“…A second blinded clinical observer, scored the same videos (inter‐observer) ICC = 0.77 (95% CI 0.63‐0.92). Bland‐Altman plots confirmed the intra and inter observer reproducibility …”

“…The parents/carers gave written consent and children their written assent [South East London Research Ethics Committee 2 ref no.10/H0802/41]. The protocol and results are already published.…”

“…The content and presentational design of the new online game was theory driven, and then thorough piloting, using a beta version, proved that the game was feasible and acceptable to family users and other healthcare stakeholders before the Phase III RCT was conducted to test it . All of the participating families had confirmed that they had access to a computer capable of playing a ‘You‐Tube’ video, and could speak English.…”

“…before the Phase III RCT was conducted to test it. [11][12][13] All of the participating families had confirmed that they had access to a computer capable of playing a 'You-Tube' video, and could speak English. They were given access to the game at home approximately two weeks in advance of the GA hospital visit and then again via a laptop on their hospital bed on the day of the surgery.…”

An oral health education video game for high caries risk children: study protocol for a randomized controlled trial

“…This number of participants is also sufficient based on our calculations using the results of the pictorial dietary quiz used in the phase-I RCT. Anticipating a 20 % dropout rate [ 30 ], we intend to recruit approximately 108 participants.…”