Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000430437
Ethics application status
Approved
Date submitted
25/04/2014
Date registered
4/04/2016
Date last updated
4/04/2016
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
Nil
Universal Trial Number (UTN)
Nil
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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.

Eligibility
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
Sex
Females
Can healthy volunteers participate?
Yes
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/04/2014
Date of last participant enrolment
Anticipated
Actual
7/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
VIC
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
Charities/Societies/Foundations
Name [1] 289132 0
Medical Research Foundation for Women and Babies
Country [1] 289132 0
Australia
Primary sponsor type
Individual
Name
Professor Sue Walker
Address
Mercy Hospital for Women
163 Studley Road, Heidelberg Victoria 3084
Country
Australia
Secondary sponsor category [1] 287796 0
None
Name [1] 287796 0
Address [1] 287796 0
Country [1] 287796 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 290910 0
23/09/2013
Approval date [1] 290910 0
14/10/2013
Ethics approval number [1] 290910 0
R13/43

Summary
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

Contacts
Principal investigator
Name 47858 0
Dr Alice Truong
Address 47858 0
Mercy Hospital for Women
163 Studley Road, Heidelberg, Victoria 3084.
Country 47858 0
Australia
Phone 47858 0
+61384584444
Fax 47858 0
Email 47858 0
[email protected]
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
Australia
Phone 47859 0
+61384584444
Fax 47859 0
Email 47859 0
[email protected]
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
Australia
Phone 47860 0
+61384584444
Fax 47860 0
Email 47860 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
SourceTitleYear of PublicationDOI
EmbaseMultimedia in improving informed consent for caesarean section: A randomised controlled trial.2020https://dx.doi.org/10.1111/ajo.13124
N.B. These documents automatically identified may not have been verified by the study sponsor.