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Trial registered on ANZCTR
Registration number
ACTRN12612001283864
Ethics application status
Not yet submitted
Date submitted
12/12/2012
Date registered
12/12/2012
Date last updated
12/12/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Viewing of a song-based videotape by pre-school aged children to reduce their anxiety before anaesthesia is commenced using a face mask.
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Scientific title
A novel technique for reducing paediatric perioperative anxiety - Children 3-6 years old randomised to watch a video depicting the anaesthesia face mask in a playful fashion - assessing level of anxiety at anaesthesia induction in children who watched the video compared with those who did not.
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Secondary ID [1]
281658
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nil
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Universal Trial Number (UTN)
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Trial acronym
FAMUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Paediatric perioperative anxiety
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Condition category
Condition code
Anaesthesiology
288326
288326
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0
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Anaesthetics
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Mental Health
288332
288332
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Viewing of a video depicting the anaesthesia face mask in a playful manner, using song and characters which have relevance to pre-schoolers. the characters in the video portray the face mask as being an object of fun. The video will be viewed as close as possible to induction, at the point that children are about to be trasported to the operating theatre holding area, ie within 1 hour of induction. The video itself will be brief, <5min.
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Intervention code [1]
286194
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Behaviour
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Intervention code [2]
286196
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Prevention
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Comparator / control treatment
No viewing of a video
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Control group
Active
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Outcomes
Primary outcome [1]
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reduction in perioperative anxiety as assessed by the mYAS (modified Yale Preoperative Anxiety Scale) which will be performed by the anaesthetic registrar
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Assessment method [1]
288497
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Timepoint [1]
288497
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at induction of anaesthesia
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Secondary outcome [1]
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nil
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Assessment method [1]
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Timepoint [1]
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nil
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Eligibility
Key inclusion criteria
Children aged 3-6 scheduled for mask induction of anaesthesia, ASA 1 or 2, having their first ever anaesthetic, who speak English as their first language
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Minimum age
3
Years
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Maximum age
6
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Diagnosed behavioural disorders or developmental delay, English not their first language, history of chronic illness or birth at <36 weeks, children who were prescibed sedative premedication
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/06/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
286454
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Self funded/Unfunded
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Name [1]
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nil
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Address [1]
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nil
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Country [1]
286454
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Primary sponsor type
Hospital
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Name
Monash Children's Hospital
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Address
246 Clayton Rd Clayton Vic 3168
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Country
Australia
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Secondary sponsor category [1]
285242
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None
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Name [1]
285242
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nil
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Address [1]
285242
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nil
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Country [1]
285242
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Research Directorate, Southern Health Network
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Ethics committee address [1]
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246 Clayton Rd Clayton Vic 3168
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Ethics committee country [1]
288532
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Australia
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Date submitted for ethics approval [1]
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14/01/2013
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Approval date [1]
288532
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Ethics approval number [1]
288532
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Summary
Brief summary
70% of children experience significant pre-operative anxiety and their anxiety levels peak at the time of mask induction. This study aims to familiarise children with the anaesthesia face mask prior to induction of anaesthesia with a cheap and readily available intervention: a playful, song based video that children will enjoy watching.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Anna Englin, Staff Paediatric Anaesthetist, Monash Children's Hospital
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Address
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246 Clayton Rd, Clayton, Vic 3168
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Country
36558
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Australia
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Phone
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+61395946666
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Fax
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Email
36558
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[email protected]
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Contact person for public queries
Name
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Dr Anna Englin
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Address
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246 Clayton Rd Clayton 3168 Vic
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Country
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Australia
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Phone
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+61395946666
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Fax
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Email
36559
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[email protected]
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Contact person for scientific queries
Name
36560
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Dr Usha Padmanabhan
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Address
36560
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246 Clayton Rd Clayton Vic 3168
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Country
36560
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Australia
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Phone
36560
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+61395946666
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Fax
36560
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Email
36560
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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