Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
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.
Secondary ID [1] 281658 0
nil
Universal Trial Number (UTN)
Trial acronym
FAMUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric perioperative anxiety 287947 0
Condition category
Condition code
Anaesthesiology 288326 288326 0 0
Anaesthetics
Mental Health 288332 288332 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286194 0
Behaviour
Intervention code [2] 286196 0
Prevention
Comparator / control treatment
No viewing of a video
Control group
Active

Outcomes
Primary outcome [1] 288497 0
reduction in perioperative anxiety as assessed by the mYAS (modified Yale Preoperative Anxiety Scale) which will be performed by the anaesthetic registrar
Timepoint [1] 288497 0
at induction of anaesthesia
Secondary outcome [1] 300320 0
nil
Timepoint [1] 300320 0
nil

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
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286454 0
Self funded/Unfunded
Name [1] 286454 0
nil
Country [1] 286454 0
Primary sponsor type
Hospital
Name
Monash Children's Hospital
Address
246 Clayton Rd Clayton Vic 3168
Country
Australia
Secondary sponsor category [1] 285242 0
None
Name [1] 285242 0
nil
Address [1] 285242 0
nil
Country [1] 285242 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288532 0
Research Directorate, Southern Health Network
Ethics committee address [1] 288532 0
246 Clayton Rd Clayton Vic 3168
Ethics committee country [1] 288532 0
Australia
Date submitted for ethics approval [1] 288532 0
14/01/2013
Approval date [1] 288532 0
Ethics approval number [1] 288532 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36558 0
Dr Anna Englin, Staff Paediatric Anaesthetist, Monash Children's Hospital
Address 36558 0
246 Clayton Rd, Clayton, Vic 3168
Country 36558 0
Australia
Phone 36558 0
+61395946666
Fax 36558 0
Email 36558 0
[email protected]
Contact person for public queries
Name 36559 0
Anna Englin
Address 36559 0
246 Clayton Rd Clayton 3168 Vic
Country 36559 0
Australia
Phone 36559 0
+61395946666
Fax 36559 0
Email 36559 0
[email protected]
Contact person for scientific queries
Name 36560 0
Usha Padmanabhan
Address 36560 0
246 Clayton Rd Clayton Vic 3168
Country 36560 0
Australia
Phone 36560 0
+61395946666
Fax 36560 0
Email 36560 0
[email protected]

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.