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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial comparing the use of a multimedia module and a written pamphlet as an adjunct to the informed consent process in patients undergoing elective caesarean section
Scientific title
A randomised control trial comparing knowledge, anxiety and satisfaction scores of patients undergoing elective caesarean section, when using a multimedia module or a written pamphlet as an adjunct to the informed consent process
Secondary ID [1] 284483 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective caesarean section 291728 0
Condition category
Condition code
Reproductive Health and Childbirth 292101 292101 0 0
Childbirth and postnatal care
Surgery 298397 298397 0 0
Other surgery

Study type
Description of intervention(s) / exposure
A 25-minute multimedia module explaining the processes expected before, during and after a caesarean section, and the risks associated with this procedure.
The module will be delivered via an iPad, 2-4 weeks prior to surgery.
Intervention code [1] 289243 0
Other interventions
Comparator / control treatment
Up to 25 minutes of reading time with the RANZCOG published pamphlets on Caesarean Section and Vaginal Birth After Caesarean Section, which will be viewed by the participant 2-4 weeks prior to surgery.
Control group

Primary outcome [1] 291977 0
Knowledge score - based on a 12-question MCQ style questionnaire, developed by the authors. Questions will be based on the content of the written pamphlet and the multimedia module, centred on the processes and risks associated with caesarean section.
Timepoint [1] 291977 0
Questionnaire administered to participants prior to the education method (module or pamphlet), immediately post-education, and on the day of surgery (2-4 weeks after education method).
Primary outcome [2] 291978 0
Anxiety Score - Spielberger State Trait Anxiety Inventory Short Form
Timepoint [2] 291978 0
Administered with the knowledge questionnaire prior to the education method, immediately post-education, and on the day of surgery (2-4 weeks after education method).
Secondary outcome [1] 307950 0
Satisfaction score - based on a Likert scale, and on a 10-point score verbally reported by the patient.
Timepoint [1] 307950 0
The Likert scale for satisfaction score will be administered immediately post-education. The verbal report of a 10-point score will be obtained over the phone on a follow up call 6 weeks post-caesarean section.

Key inclusion criteria
Patients undergoing elective caesarean section - either for the first time, or as first repeat caesarean section. English must be primary language.
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
English not primary language - i.e. intrepreter required.
Higher order repeat caesarean sections (i.e. > 1 previous caesarean section).

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)
Patients on the upcoming booked elective caesarean section theatre lists are identified as suitable for the study. Suitable patients are approached at their antenatal appointment 2-4 weeks prior to their theatre date. Patients are consented for the study prior to randomisation. They are administered the pre-education questionnaire. They are then randomised to either the control or intervention group. After randomisation, they will receive their allocated method of education (pamphlet or multimedia module), and complete their post-education questionnaire. On the day of their surgery, they will be administered a 3rd questionnaire. Six weeks following their operation, they will be contacted by phone to assess their satisfaction score with their method of education.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients are randomised into either control or intervention group using a computerised randomisation program "Sealed Envelope". Each participant's allocated group is placed into opaque envelopes, and not opened until the patient consented to participate in the study. Neither researcher nor patient will be aware of which group the participant will be allocated to prior to consent for the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The required sample size is 27 per group. This was calculated using the two-sample t- test, based on a power test of 0.8 and assuming a knowledge difference between groups of 15%. We will compare means/median of knowledge/anxiety scores between the intervention and control group using T test/Mann Whitney U test.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 2361 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 8025 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 289132 0
Name [1] 289132 0
Medical Research Foundation for Women and Babies
Address [1] 289132 0
Level 1, 380 Victoria Parade, East Melbourne, Victoria, 3002.
Country [1] 289132 0
Primary sponsor type
Professor Sue Walker
Mercy Hospital for Women
163 Studley Road, Heidelberg Victoria 3084
Secondary sponsor category [1] 287796 0
Name [1] 287796 0
Address [1] 287796 0
Country [1] 287796 0

Ethics approval
Ethics application status
Ethics committee name [1] 290910 0
Mercy Health Human Research Ethics Committee (Mercy Health HREC)
Ethics committee address [1] 290910 0
163 Studley Road, Heidelberg Victoria 3084
Ethics committee country [1] 290910 0
Date submitted for ethics approval [1] 290910 0
Approval date [1] 290910 0
Ethics approval number [1] 290910 0

Brief summary
In this study, we will be looking at the education process as a part of informed consent prior to an elective caesarean section. In particular, we will be comparing a 25-minute multimedia module that we have developed, with the current RANZCOG published written pamphlets on caesarean section and vaginal birth after caesarean section. We hypothesise that the multimedia module will compare favourably in terms of improved knowledge and satisfaction scores, and reduced anxiety scores in comparison to the written pamphlets that patients currently receive.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 47858 0
Dr Alice Truong
Address 47858 0
Mercy Hospital for Women
163 Studley Road, Heidelberg, Victoria 3084.
Country 47858 0
Phone 47858 0
Fax 47858 0
Email 47858 0
Contact person for public queries
Name 47859 0
Dr Alice Truong
Address 47859 0
Mercy Hospital for Women
163 Studley Road, Heidelberg, Victoria 3084.
Country 47859 0
Phone 47859 0
Fax 47859 0
Email 47859 0
Contact person for scientific queries
Name 47860 0
Dr Alice Truong
Address 47860 0
Mercy Hospital for Women
163 Studley Road, Heidelberg, Victoria 3084.
Country 47860 0
Phone 47860 0
Fax 47860 0
Email 47860 0

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary