Contact information
Type
Scientific
Primary contact
Prof Marie Therese Hosey
ORCID ID
Contact details
Kings College Dental Institute
Bessemer Road
Denmark Hill
London
SE5 9RS
United Kingdom
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m.t.hosey@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10006
Study information
Scientific title
Improving access to preparatory information for children undergoing general anaesthesia for surgical dental procedures and their families
Acronym
Study hypothesis
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
10/H0802/41
Study design
Randomised interventional double-blind three-armed trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
04/07/2012
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
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
Participant exclusion criteria
1. Do not consent to participate
2. Prior experience of GA
3. No PC ownership
4. Child has learning disability
Recruitment start date
04/07/2012
Recruitment end date
31/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Kings College Dental Institute
London
SE5 9RS
United Kingdom
Sponsor information
Organisation
King's College Hospital NHS Foundation Trust (UK)
Sponsor details
NICU
Denmark Hill
London
SE5 9RS
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Research for Patient Benefit Programme Grant Codes: PB-PG-1208-17227
Alternative name(s)
NIHR Research for Patient Benefit Programme, RfPB
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24919430
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28882136
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29280239
Publication citations
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Protocol
Hosey MT, Donaldson AN, Huntington C, Liossi C, Reynolds PA, Alharatani R, Newton JT, 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, 2014, 15, 219, doi: 10.1186/1745-6215-15-219.