Condition category
Oral Health
Date applied
29/11/2013
Date assigned
29/11/2013
Last edited
13/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
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 child’s 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.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10006

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 below 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 child’s GA experience).

Study Entry: Multiple Randomisations

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

Adult

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

http://www.kch.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit (RfPB) (UK) Grant Codes: PB-PG-1208-17227

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24919430

Publication citations

  1. 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.

Additional files

Editorial Notes