Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000710921
Ethics application status
Not yet submitted
Date submitted
6/07/2011
Date registered
11/07/2011
Date last updated
11/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Antenatal Education for Epidural Anaesthesia in Labour - A Pilot Study
Scientific title
To determine the efficacy of the use of multimedia patient education technology in the antenatal education process, particularly regarding the use of epidural anaesthesia in labour, in primigravida women who are planning on having a normal vaginal delivery.
Secondary ID [1] 262578 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain during labour in primigravida women planning to have a normal vaginal delivery. 268241 0
Condition category
Condition code
Reproductive Health and Childbirth 268372 268372 0 0
Antenatal care
Reproductive Health and Childbirth 268416 268416 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention arm will be given the opportunity to watch a multimedia patient education module (approximately 20 minutes in length) on the use of epidural anaesthesia in labour during their antenatal education classes at 32 weeks gestation.
Intervention code [1] 266908 0
Other interventions
Comparator / control treatment
The control arm will have the usual antenatal education regarding the process of labour which includes being given a pamphlet promulgated by the Australian Society of Anaesthetists.
Control group
Active

Outcomes
Primary outcome [1] 269140 0
The study aims to examine the opinions of women regarding their concerns about pain relief in labour by comparing the efficacy of a pamphlet and of a multimedia module in explaining risks and benefits of epidural anaesthesia in labour and to determine whether patient anxiety levels are influenced by being given information regarding epidural anaesthesia in labour. Patients will be asked to complete a knowledge based questionnaire prior to information delivery as well as a state-trait anxiety questionnaire. A knowledge questionnaire and anxiety questionnaire will also be completed by the patients after receiving the information. At 2 week post delivery of a healthy baby the midwife who conducted the classes will get the patients to complete a questionnaire regarding their experience with epidural anaesthesia during the birthing process.
Timepoint [1] 269140 0
The outcome will be assessed immediately after information delivery and also at 2 weeks post delivery during the patients routine checkup.
Secondary outcome [1] 279004 0
To obtain subjective assessment of patients regarding whether they believed the antenatal education that they received adequately prepared them for what they experienced, particularly regarding epidural anaesthesia in labour.
Timepoint [1] 279004 0
In the two weeks following delivery of a healthy baby. This will be assessed via a postnatal questionnaire conducted by the midwife during the patients postnatal check up.

Eligibility
Key inclusion criteria
Patients must be primigravida women who are planning on having a normal vaginal delivery. Patients must be aged between 20 and 40 years, have no past history of epidural or spinal anaesthesia, english must be their first language, have achieved grade 11 or greater secondary education and be able to read a plain English patient information consent form. Patients also need to be attending the antenatal education classes conducted by Ms Cathryn Curtin at the Epworth Freemasons Maternity Hospital.
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are maternal age less than 20 or greater than 40 years, English not primary language, poor eyesight and/or hearing, previous epidural or spinal anaesthesia and planned 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 who fit the inclusion criteria will be identified by their Obstetrician - Dr Len Kliman. Dr Kliman will explain the study and instruct patients to confirm their willingness to participate in the trial when they book their antenatal classes. During classes confirmed participants will be randomly allocated to the pamphlet or multi media module groups. Patients will be randomly allocated into the two groups using sealed envelopes produced by the Clinical Trials and Research Centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267382 0
Charities/Societies/Foundations
Name [1] 267382 0
Epworth Foundation - Foot and Ankle Research Fund
Country [1] 267382 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Epworth Foundation - Foot and Ankle Research Fund
Address
32 Erin Street
Richmond
Vic 3121
Country
Australia
Secondary sponsor category [1] 266443 0
None
Name [1] 266443 0
Address [1] 266443 0
Country [1] 266443 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269357 0
Epworth Healthcare
Ethics committee address [1] 269357 0
89 Bridge Road
Richmond
Victoria
3121
Ethics committee country [1] 269357 0
Australia
Date submitted for ethics approval [1] 269357 0
03/08/2011
Approval date [1] 269357 0
Ethics approval number [1] 269357 0

Summary
Brief summary
We hypothesise that multi-media patient education technology is superior to pamphlet delivery of this information. A secondary hypothesis is that increased understanding of epidural anaesthetic in labour will increase patient anxiety levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32838 0
Address 32838 0
Country 32838 0
Phone 32838 0
Fax 32838 0
Email 32838 0
Contact person for public queries
Name 16085 0
Kate Claxton
Address 16085 0
Epworth Centre
Suite 6.3, Level 6
32 Erin Street
Richmond
Vic 3121
Country 16085 0
Australia
Phone 16085 0
+61 3 9428 9944
Fax 16085 0
+61 3 9428 3444
Email 16085 0
kate@footsurgeon.com.au
Contact person for scientific queries
Name 7013 0
Kate Claxton
Address 7013 0
Epworth Centre
Suite 6.3, Level 6
32 Erin Street
Richmond
Vic 3121
Country 7013 0
Australia
Phone 7013 0
+61 3 9428 9944
Fax 7013 0
+61 3 9428 3444
Email 7013 0
kate@footsurgeon.com.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.