Preparatory information for children undergoing general anaesthesia

ISRCTN	ISRCTN18265148
DOI	https://doi.org/10.1186/ISRCTN18265148
Secondary identifying numbers	10006

Submission date: 29/11/2013
Registration date: 29/11/2013
Last edited: 19/11/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marie Therese Hosey
Scientific

Kings College Dental Institute
Bessemer Road
Denmark Hill
London
SE5 9RS
United Kingdom

ORCID ID	0000-0003-1178-4106
Email	m.t.hosey@kcl.ac.uk

Study information

Study design	Randomised interventional double-blind three-armed trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Improving access to preparatory information for children undergoing general anaesthesia for surgical dental procedures and their families
Study objectives	Phase III evaluation will use a double-blind three-armed RCT design. The clinical trial will recruit up to 210 children and will compare the web-based version of the package against standard care and another non-medical game. Distress will be assessed through evaluation of the childs behaviour during the visit and parental reports of physical and psychological morbidity. The views of parents and children will be sought; the mode of usage of the web-based package will be automatically recorded and the impact on the service e.g. recovery time and throughput will be reported. At least 53 in each group will be required for 90% statistical power. The Phase III study primary outcome measures: (1) patient experience: acceptance of anaesthetic induction; child co-operation/distress; reduction of peri- and post-operative morbidity; child and family satisfaction and (2) service improvement: anaesthetic time/improvement in throughput. Measures will be administered at baseline, at the time of the GA treatment visit and then at 48 hours and 1 week later.
Ethics approval(s)	10/H0802/41
Health condition(s) or problem(s) studied	Topic: Oral and Gastrointestinal, Generic Health Relevance and Cross Cutting Themes; Subtopic: Oral and Gastrointestinal (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Oral & Dental, Anaesthetics
Intervention	The clinical trial will compare the web-based version of the package against standard care and another non-medical game. Online serious game intervention will include: modelling appropriate behaviour, coping skill teaching, provision of information in a developmentally appropriate manner and parent involvement (how to help their child get the most out of the intervention and what they can do themselves to improve their childs GA experience). Study Entry: Multiple Randomisations
Intervention type	Other
Primary outcome measure	1. Blind observer VAS scores of behaviour at anaesthetic induction 2. Child cooperation and dist
Secondary outcome measures	Automatic recording of internet package usage will occur.
Overall study start date	04/07/2012
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	7 Years
Sex	Both
Target number of participants	Planned Sample Size: 210; UK Sample Size: 210; Description: Based on acceptance of anaesthetic induction measured using a Visual Analogue Scale
Key inclusion criteria	1. Consent to participate 2. Literate in English 3. Own a PC with internet access 4. No previous experience of general anaesthesia 5. Target Gender: Male & Female; Upper Age Limit 7 years; Lower Age Limit 5 years
Key exclusion criteria	1. Do not consent to participate 2. Prior experience of GA 3. No PC ownership 4. Child has learning disability
Date of first enrolment	04/07/2012
Date of final enrolment	31/12/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Kings College Dental Institute

London
SE5 9RS
United Kingdom

Sponsor information

King's College Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

NICU, Denmark Hill
London
SE5 9RS
England
United Kingdom

Website	http://www.kch.nhs.uk/
"ROR"	https://ror.org/01n0k5m85

Funders

Funder type

Government

Research for Patient Benefit Programme Grant Codes: PB-PG-1208-17227
Government organisation / National government

Alternative name(s): NIHR Research for Patient Benefit Programme, RfPB
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	11/06/2014		Yes	No
Results article	results	07/09/2017		Yes	No
Results article	results	01/02/2018		Yes	No
Results article	results	01/11/2018		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

19/11/2018: Publication reference added.
12/11/2018: The scientific contact's ORCID ID has been added.
04/10/2018: Publication references added.