Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000572268
Ethics application status
Approved
Date submitted
21/03/2009
Date registered
14/07/2009
Date last updated
14/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of Preanaesthetic Consultation on patient anxiety
Scientific title
The effect of the Preanaesthetic Consultation on anxiety in patients scheduled for general anaesthesia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 4513 0
Condition category
Condition code
Anaesthesiology 4794 4794 0 0
Other anaesthesiology
Mental Health 4795 4795 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A one off standard anaesthetic consultation between one anaesthetist and one patient lasting up to half an hour.
Intervention code [1] 236907 0
Other interventions
Intervention code [2] 236908 0
Treatment: Other
Comparator / control treatment
No pre-anaesthetic consultation
Control group
Active

Outcomes
Primary outcome [1] 5656 0
Anxiety as measured by 100mm Visual Analogue Scale (VAS) and Pre-operative Intrusive Thought Inventory (PITI) Scale
Timepoint [1] 5656 0
Within two hours of seeing the anaesthetist for a preanaesthetic check
Primary outcome [2] 238340 0
Anxiety as measured by 100mm Visual Analogue Scale (VAS) and Pre-operative Intrusive Thought Inventory (PITI) Scale
Timepoint [2] 238340 0
Within one hour after seeing the anaesthetist for a preanaesthetic consultation
Secondary outcome [1] 244748 0
Nil
Timepoint [1] 244748 0
Nil

Eligibility
Key inclusion criteria
Patients waiting to see the anaesthetist prior to general anaesthesia
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
deaf / Blind
Unable to give informed consent
requires a translator
General Anaesthesia contra-indicated

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)
Consectiively numbered sealed opaque envelopes containing the randomisation sequence will be opened once participant has consented to participate
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2009
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)

Funding & Sponsors
Funding source category [1] 4700 0
Self funded/Unfunded
Name [1] 4700 0
Country [1] 4700 0
Primary sponsor type
Individual
Name
Dr Allan M Cyna
Address
Department of Anaesthesia, 72 King William Rd, Women's and Children's Hospital, Adelaide, SA 5006
Country
Australia
Secondary sponsor category [1] 4246 0
None
Name [1] 4246 0
Address [1] 4246 0
Country [1] 4246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6735 0
Women's and Children's Hospital human Research ethics committee
Ethics committee address [1] 6735 0
Women's and Children's Hospital, 72 King william Rd, Adelaide, SA 5006
Ethics committee country [1] 6735 0
Australia
Date submitted for ethics approval [1] 6735 0
Approval date [1] 6735 0
Ethics approval number [1] 6735 0

Summary
Brief summary
To assess the effect of the pre-anaesthetic consultation on patient anxiety prior to a planned general anaesthetic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29424 0
Address 29424 0
Country 29424 0
Phone 29424 0
Fax 29424 0
Email 29424 0
Contact person for public queries
Name 12671 0
Dr A.M.Cyna
Address 12671 0
Dept. Women's Anaesthesia, Women's and Children's Hospital, 72 King William Rd, Adelaide SA 5006
Country 12671 0
Australia
Phone 12671 0
+61 8 81617630
Fax 12671 0
Email 12671 0
allan.cyna@health.sa.gov.au
Contact person for scientific queries
Name 3599 0
Dr Allan M Cyna
Address 3599 0
Dept. Women's Anaesthesia, Women's and Children's Hospital, 72 King William Rd, Adelaide SA 5006
Country 3599 0
Australia
Phone 3599 0
+61 8 81617630
Fax 3599 0
Email 3599 0
allan.cyna@health.sa.gov.au

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.