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Trial registered on ANZCTR


Registration number
ACTRN12611001207909
Ethics application status
Approved
Date submitted
22/11/2011
Date registered
23/11/2011
Date last updated
1/12/2023
Date data sharing statement initially provided
23/11/2018
Date results provided
23/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the use of a patient information video affect maternal antenatal anxiety and post-natal maternal satisfaction after elective caesarean delivery?
Scientific title
Does the use of a patient information video affect maternal antenatal anxiety and post-natal maternal satisfaction for patients who have not previously experienced elective caesarean section?
Secondary ID [1] 273438 0
Nil
Universal Trial Number (UTN)
U1111-1125-9887
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety levels before elective caesarean section 279223 0
Satisfaction with anaesthesia for caesarean section scores after elective caesarean section 279224 0
Condition category
Condition code
Anaesthesiology 279431 279431 0 0
Anaesthetics
Mental Health 279436 279436 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who have not previously had an elective caesarean section will be randomised to a study group that sees a patient information video prior to their anaesthetic appointment or a control group that has usual care. Anxiety levels will be measured after the anaesthetic interview and maternal satisfaction scores will be measured on the first post operative day.
The study group will watch a Patient information video: "Your Anaesthetic for Caesarean section at the Royal Brisbane and Womens hospital" before their interview with the anaesthetist. The video will be 4-5 minutes long and will be viewed once. The video is not intended to replace informed consent but to convey a typical patient experience. It will include information regarding preparation for theatre, insertion of an intravenous cannula, application of monitoring, insertion of a neuraxial anaesthetic, monitoring of the baby and insertion of indwelling catheter. The video does not include information specific to the operation.
Intervention code [1] 283768 0
Behaviour
Comparator / control treatment
The control group will receive usual care - an interview with an anaesthetist. This follows a proforma provided by the hospital - history, examination and review of investigations. A discussion of anaesthetic options and the risks and benefits of each option occurs. There is a description of the proposed anaesthetic technique.
Control group
Active

Outcomes
Primary outcome [1] 286000 0
The anxiety levels as measured by Spielberger's Stait-Trait Anxiety Inventory.
Timepoint [1] 286000 0
Measured after the anaesthetic interview.
Secondary outcome [1] 294939 0
Patient satisfaction with their anaesthetic for caesarean section measured by the "Maternal Satisfaction with Caesarean Section Scale".
Timepoint [1] 294939 0
Measured on post-operative day 1.
Secondary outcome [2] 294940 0
The duration of the anaesthetic interview measured in minutes.
Timepoint [2] 294940 0
Measured on the day of the anaesthetic interview.
Secondary outcome [3] 294941 0
Satisfaction with information provided at the anaesthetic appointment, measured on a 7 point Likert scale.
Timepoint [3] 294941 0
Post-operative day 1.

Eligibility
Key inclusion criteria
Booked for elective caesarean section.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous elective caesarean section.
Planned general anaesthetic.
Unable to complete a questionnaire written in english or understand a video presented in english.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be by opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be obtained using a randomisation table from a statistical book. Block randomisation will be used. The groups will be stratified according to whether or not the participant has had a previous emergency caesarean section before.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2012
Actual
22/09/2011
Date of last participant enrolment
Anticipated
Actual
6/12/2012
Date of last data collection
Anticipated
Actual
7/02/2013
Sample size
Target
100
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 284246 0
Hospital
Name [1] 284246 0
Department of Anaesthesia, Royal Brisbane and Womens' Hospital
Country [1] 284246 0
Australia
Funding source category [2] 284247 0
Hospital
Name [2] 284247 0
Royal Brisbane and Womens' Hospital, Department of Anaesthesia
Country [2] 284247 0
Australia
Primary sponsor type
Individual
Name
Dr Victoria Eley
Address
Department of Anaesthesia
Royal Brisbane and Womens' Hospital
Butterfield St
Herston
4006
Queensland
Country
Australia
Secondary sponsor category [1] 269202 0
Individual
Name [1] 269202 0
Dr Tisha Searles
Address [1] 269202 0
Department of Anaesthesia
Royal Brisbane and Womens' Hospital
Butterfield St
Herston
4006
Queensland
Country [1] 269202 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286212 0
Royal Brisbane and Womens' Hospital Human Ethics and Research Committee
Ethics committee address [1] 286212 0
Ethics committee country [1] 286212 0
Australia
Date submitted for ethics approval [1] 286212 0
22/11/2011
Approval date [1] 286212 0
23/01/2012
Ethics approval number [1] 286212 0
HREC11QRBW463

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33425 0
Dr Victoria Eley
Address 33425 0
The Royal Brisbane and Women's Hospital
Butterfield St
Herston 4006
QLD
Country 33425 0
Australia
Phone 33425 0
+617 438127616
Fax 33425 0
Email 33425 0
va_eley@hotmail.com
Contact person for public queries
Name 16672 0
Victoria Eley
Address 16672 0
Department of Anaesthesia
Royal Brisbane and Womens' Hospital
Butterfield St
Herston
Queensland 4006
Country 16672 0
Australia
Phone 16672 0
617 36361775
Fax 16672 0
Email 16672 0
victoria_eley@health.qld.gov.au
Contact person for scientific queries
Name 7600 0
Dr Victoria Eley
Address 7600 0
Department of Anaesthesia
Royal Brisbane and Womens' Hospital
Butterfield St
Herston
Queensland 4006
Country 7600 0
Australia
Phone 7600 0
617 36361775
Fax 7600 0
Email 7600 0
victoria_eley@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.