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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000430437

Enrollment

Registered

2016-04-04

Start date

2014-04-04

Completion date

2015-08-07

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Patients undergoing elective caesarean section - either for the first time, or as first repeat caesarean section. English must be primary language.

Exclusion criteria

English not primary language - i.e. intrepreter required. Higher order repeat caesarean sections (i.e. > 1 previous caesarean section).

Outcome results