Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000434897
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
16/04/2021
Date last updated
5/04/2022
Date data sharing statement initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness and Usability of an Immersive Virtual-Reality (IVR) Imminent Birth Program
Scientific title
The Effectiveness and Usability of an Immersive Virtual-Reality (IVR) Imminent Birth Education Program for Education of Non-Midwifery Nursing Students in Rural and Remote Locations – A Pilot Randomised Control Trial Study.
Secondary ID [1] 303403 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childbirth 320609 0
Condition category
Condition code
Reproductive Health and Childbirth 318461 318461 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study aims to examine the effectiveness and usability of conducting the Imminent
Birth (IB) Program with immersive virtual reality (IVR). We are comparing the outcomes from
the IVR version of the program to those from the traditional face-to-face version of the
program.

1. Online pre-reading - The existing Imminent Birth Program has an online, evidence based course for participants to access for pre-reading prior to attending a face to face workshop. The reading consists of four modules: 1. Promoting Normal Birth; 2. Rural and Remote Practice; 3. Labour and Birth; and 4. When Problems Arise. These modules provide a review of normal female anatomy and physiology of pregnancy, the birthing process, recognising deviations from normal and appropriate referral pathways. The pre-reading material is available via the iLearn platform and accessible through Queensland Health to all students on placement. The modules include readings, short videos and quizzes to assess learning. The student participants will complete the online component over a four hour period prior to the simulation scenarios. A variation has been made from the existing Imminent Birth program in order to deliver the RCT in a single day format. Therefore, whereas the existing IB program involves a content review to bridge the gap in time between the pre reading and the simulation workshops, this is not applicable as pre-reading is completed immediately prior to simulation.

2. Practice scenarios - The Imminent Birth Program includes simulation of a low risk vaginal birth, enabling each student to have the opportunity to demonstrate the skills required to assist with a normal birth. The simulation activity aims to elicit skills including summoning appropriate help, assessing the stage of labour, supporting a woman during labour, and assessing the baby after birth to determine the need for resuscitation. Following the scenario there is an opportunity to debrief and check performance against a checklist. Half of the nursing students will be randomised to one low fidelity simulation scenario (the control group) and the other half to one immersive virtual reality simulation scenario (the intervention group). The students will be able to repeat the simulations activities several times within the allocated ninety minutes. For the intervention group, the virtual reality headsets will be outfitted with Oculus Quest All-In-One systems, which provides the participant a physically and visually immersive virtual environment via two 1440 x 1600 pixel screens. It has two wireless controllers to allow for an intuitive way to interact with the environment. With Oculus’s partnership with Unity we can import 3D models that interact with the controllers and allow us to customise the object in the environment for each individual scenario.

3. Who and their expertise - The online reading will be supervised by registered nurses and midwives; The face to face simulation will be conducted by registered midwives; The immersive virtual reality will be supervised by IT support, the observing research team and registered nurses.

4. Location - One day workshops will be held at locations in Brisbane and Toowoomba.
Intervention code [1] 319659 0
Treatment: Devices
Intervention code [2] 319998 0
Behaviour
Comparator / control treatment
Group 1 will be the 'control group' which will receive the existing face to face
simulation scenario of the Imminent Birth program. This will be conducted using a low fidelity birth simulator model. The control group differs from the 'intervention group' in that they will perform the simulation hands on, whilst the intervention group will instead perform their simulation via virtual reality headset. The students from both groups will be able to repeat the simulation activities several times within the allocated ninety minutes.
Control group
Active

Outcomes
Primary outcome [1] 326464 0
Knowledge gained for the control face to face group and the intervention immersive virtual reality simulation group, measured using a pre, post and follow up knowledge survey. The survey has been developed using the questions in the online quiz in the existing Imminent Birth online modules via iLearn.
Timepoint [1] 326464 0
Pre and post workshop and two week follow up survey.
Primary outcome [2] 326492 0
Assess the usability of Immersive Virtual Reality as an educational tool using a System Usability Scale (SUS)..
Timepoint [2] 326492 0
At the end of the workshop.
Primary outcome [3] 326847 0
Evaluate the modality of Immersive Virtual Reality as an alternative delivery option, using qualitative focus groups interviews which will be audio recorded.
Timepoint [3] 326847 0
At the end of the workshop.
Secondary outcome [1] 391564 0
Self reported confidence in clinical practice achieved between face to face simulation and Immersive Virtual Reality simulation groups measured using the existing Imminent Birth Program confidence survey which will be applied pre, post and at two weeks follow up.
Timepoint [1] 391564 0
Pre and post workshop and two week follow up survey.

Eligibility
Key inclusion criteria
Eligible participants will be undergraduate health students who are in a university degree program.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those health students with a self-reported history of seizures will be excluded from participating.

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)
Random allocation will be concealed to project team members who determine whether a participant is eligible for inclusion in the trial.
Randomisation will be performed by a project team member not involved in eligibility screening and blinded to the identity of eligible participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated permuted block randomisation via http://randomization.com
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
With a total sample size of 28, power at 80%, and alpha at 0.05, the model will be sensitive enough to detect effects as small as f = 0.25, which is a medium effect size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2021
Actual
17/05/2021
Date of last participant enrolment
Anticipated
31/05/2021
Actual
24/06/2021
Date of last data collection
Anticipated
28/06/2021
Actual
12/07/2021
Sample size
Target
28
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 32993 0
4350 - Toowoomba
Recruitment postcode(s) [2] 32994 0
4067 - St Lucia

Funding & Sponsors
Funding source category [1] 307763 0
University
Name [1] 307763 0
Southern Queensland Rural Health
Country [1] 307763 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Baillie Henderson Hospital campus
Torr Street
Toowoomba, Qld, 4350
Country
Australia
Secondary sponsor category [1] 308466 0
None
Name [1] 308466 0
Address [1] 308466 0
Country [1] 308466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307786 0
University of Queensland Health and Behavioural Sciences Low and Negligible Risk Ethics Sub-Committee
Ethics committee address [1] 307786 0
Ethics committee country [1] 307786 0
Australia
Date submitted for ethics approval [1] 307786 0
07/01/2021
Approval date [1] 307786 0
21/01/2021
Ethics approval number [1] 307786 0
2020003109

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

Contacts
Principal investigator
Name 108486 0
Mrs Helen Goodwin
Address 108486 0
Southern Queensland Rural Health
Baillie Henderson Hospital campus
Torr Street
Toowoomba, 4350
Queensland
Country 108486 0
Australia
Phone 108486 0
+61 7 46339782
Fax 108486 0
Email 108486 0
[email protected]
Contact person for public queries
Name 108487 0
Helen Goodwin
Address 108487 0
Southern Queensland Rural Health
Baillie Henderson Hospital campus
Torr Street
Toowoomba, 4350
Queensland
Country 108487 0
Australia
Phone 108487 0
+61 7 46339782
Fax 108487 0
Email 108487 0
[email protected]
Contact person for scientific queries
Name 108488 0
Helen Goodwin
Address 108488 0
Southern Queensland Rural Health
Baillie Henderson Hospital campus
Torr Street
Toowoomba, 4350
Queensland
Country 108488 0
Australia
Phone 108488 0
+61 7 46339782
Fax 108488 0
Email 108488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected]).


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.