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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.

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.
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.

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.
general anaesthesia, children, preparatory information, coping, cognitive behavioural therapy, role modelling, early childhood caries, dental anxiety, randomized controlled trial (RCT)
1745-6215
Hosey, M.T.
b12174cc-5c1d-4732-ada8-e7ccb9f57a86
Donaldson, A.N.
05c45d0c-267f-4cf1-b241-5e3bf31f11af
Huntington, C.
101911e8-06f3-4896-9d1a-24cc9df95076
Liossi, Christina
fd401ad6-581a-4a31-a60b-f8671ffd3558
Reynolds, P.A.
b980f807-df65-453a-a05e-98f763643ab8
Alharatani, R.
98c27895-ea07-4dd8-bf1a-8283987f7c85
Newton, J.T.
81f937af-95cd-4c99-9d86-6a3122af5d99
Hosey, M.T.
b12174cc-5c1d-4732-ada8-e7ccb9f57a86
Donaldson, A.N.
05c45d0c-267f-4cf1-b241-5e3bf31f11af
Huntington, C.
101911e8-06f3-4896-9d1a-24cc9df95076
Liossi, Christina
fd401ad6-581a-4a31-a60b-f8671ffd3558
Reynolds, P.A.
b980f807-df65-453a-a05e-98f763643ab8
Alharatani, R.
98c27895-ea07-4dd8-bf1a-8283987f7c85
Newton, J.T.
81f937af-95cd-4c99-9d86-6a3122af5d99

Hosey, M.T., Donaldson, A.N., Huntington, C., Liossi, Christina, Reynolds, P.A., Alharatani, R. and Newton, J.T. (2014) 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. Trials. (doi:10.1186/1745-6215-15-219).

Record type: Article

Abstract


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.

Full text not available from this repository.

More information

Published date: 11 June 2014
Keywords: general anaesthesia, children, preparatory information, coping, cognitive behavioural therapy, role modelling, early childhood caries, dental anxiety, randomized controlled trial (RCT)
Organisations: Psychology

Identifiers

Local EPrints ID: 372035
URI: https://eprints.soton.ac.uk/id/eprint/372035
ISSN: 1745-6215
PURE UUID: b4f6c27d-781f-4c6a-bae8-96685067da00
ORCID for Christina Liossi: ORCID iD orcid.org/0000-0003-0627-6377

Catalogue record

Date deposited: 26 Nov 2014 13:15
Last modified: 13 Jun 2019 00:35

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Contributors

Author: M.T. Hosey
Author: A.N. Donaldson
Author: C. Huntington
Author: P.A. Reynolds
Author: R. Alharatani
Author: J.T. Newton

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