Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001065482
Ethics application status
Approved
Date submitted
11/09/2025
Date registered
29/09/2025
Date last updated
29/09/2025
Date data sharing statement initially provided
29/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing Rapid Cycle Deliberate Practice and traditional Simulation on nurses' performance in a simulated scenario
Scientific title
A Randomised Controlled Trial Comparing Rapid Cycle Deliberate Practice (RCDP) and Traditional Immersive Simulation (TIS) On Nurses' Resuscitation Performance in a Simulated Scenario
Secondary ID [1] 315304 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resuscitation 338774 0
Condition category
Condition code
Emergency medicine 335069 335069 0 0
Resuscitation
Public Health 335216 335216 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the intervention arm will receive Rapid Cycle Deliberate Practice (RCDP) as an education method for resuscitation training.
In this intervention arm, participants will receive training over one hour, Face to Face, on one allocated day:

- 5-minute pre brief and Basic Life Support confidence survey

- 20-minute RCDP resuscitation training session - Participants work through a clinical scenario which is broken up into small sections. During each section participants practice clinical skills (e.g. CPR, Defibrillation, and Airway skills and are provided with immediate feedback and debriefing. Sections are then repeated until skill mastery is achieved.

- 5-minute NASA TLX - Participants will complete the NASA TLX tool immediately after the RCDP training session. The NASA TLX is a tool used to assess self perceived workload. It measures six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration. This tool will assist in assessing cognitive load of training received. NASA TLX sourced from NASA Human Systems Integration Division.

- 10-minute uninterrupted clinical scenario. Participants work through a full clinical scenario (e.g. cardiac arrest scenario) using a manikin. The scenario runs without instructor interruption to capture team resuscitation performance (e.g. CPR quality, timely defibrillation),
- 20 minute debrief.

* Informational materials that would be used include:
- Scenario guides (includes simulated clinical notes for participants to use during their simulation). Designed specifically for this study.
- Facilitator guides (instructions for running simulations/training sessions). Designed specifically for this study.
- Debriefing tool to facilitate debriefing. Sourced from St George Hospital and Debreif2Learn.org
- Basic Life Support education poster. Sourced from the Australian Resuscitation Council
* Physical materials:
- Laerdal QCPR Mannequin
- Simulated defibrillator - Realiti Sourced from iSimulate
- Clinical equipment (resuscitation equipment - Airway equipment)

The training sessions within this intervention arm will be delivered by Nursing educators who have been trained in RCDP method.
The location of the intervention will be in a purpose-built education center e.g. Clinical Skills Centre within an acute in-patient hospital.

Adherence to the intervention will be through direct observation. Researchers will be using facilitator guides during training sessions to ensure intervention adherence occurs.
Intervention code [1] 331907 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control arm will receive Traditional Immersive Simulation (TIS) as an education method for resuscitation training.
In this arm, the participants will receive training over one hour. Face to Face. On one allocated day:
- 5-minute pre brief & BLS confidence survey
-20-minute Resuscitation TIS training session. Which involves a demonstration of Basic Life Support maneuvers performed by the researchers, theory review of Basic Life Support, and a clinical resuscitation simulation participants will participate in. This scenario runs from start to finish without interruption from researchers.
-5-minute NASA TLX
-10-minute recorded uninterrupted simulated resuscitation scenario
-20-minutes debrief

The training sessions within the control arm will be delivered by Nursing educators who have been trained in TIS method.
he location of the intervention will be in a purpose-built education center e.g. Clinical Skills Centre within an acute in-patient hospital.
Control group
Active

Outcomes
Primary outcome [1] 342701 0
Time taken to delivery of defibrillation in a simulated scenario
Timepoint [1] 342701 0
Time interval (seconds) between the onset of cardiac arrest and delivery of first defibrillation during a simulated clinical scenario.
Secondary outcome [1] 451867 0
Perceived cognitive load associated with training method used (RCDP vs TIS)
Timepoint [1] 451867 0
Outcome will be assessed following simulation training method delivery.
Secondary outcome [2] 452287 0
Time taken to first chest compression in a simulated clinical scenario
Timepoint [2] 452287 0
Time interval (seconds) between the onset of cardiac arrest and first chest compression during a simulated clinical scenario. Data will be obtained from uninterrupted video recording
Secondary outcome [3] 452291 0
To measure chest compression quality.: chest compression rate,
Timepoint [3] 452291 0
Chest compression rate will be captured using the Little Annie qCPR Laerdal mannequin. Data will be obtained after the simulated scenario has been competed
Secondary outcome [4] 452638 0
To measure chest compression quality: chest compression depth
Timepoint [4] 452638 0
Chest compression depthwill be captured using the Little Annie qCPR Laerdal mannequin. Data will be obtained after the simulated scenario has been competed
Secondary outcome [5] 452639 0
To measure chest compression quality: chest compression fraction
Timepoint [5] 452639 0
Chest compression depth will be captured using the Little Annie qCPR Laerdal mannequin. Data will be obtained after the simulated scenario has been competed.
Secondary outcome [6] 452640 0
To measure chest compression quality: chest compression no flow.
Timepoint [6] 452640 0
Chest compression no flow time will be captured using the Little Annie qCPR Laerdal mannequin. Data will be obtained after the simulated scenario has been competed.

Eligibility
Key inclusion criteria
Nurses employed in an acute care in patient hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unable to give consent
2. Nurses who have previously received RCDP resuscitation training
3. Registered Midwife (direct entry midwife)

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)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization with block sizes of four or six using blockrand in R.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The following assumptions regarding the endpoint of time from cardiac arrest to first defibrillation are made for the sample size calculation:

Estimated average time to defibrillation is 150 seconds

Estimated improvement in first defibrillation time is 30 seconds and a standard deviation of 30 seconds.

Based on the above assumptions and findings from previous studies it is projected that approximately 230 participants will be needed to form a total 46 teams (up to 5 participants in each team). Using a two sided test with alpha of 0.05 and 90% power (beta of 0.10), the sample size calculation estimates a requirement of 23 teams per arm.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28416 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 44644 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 319878 0
Government body
Name [1] 319878 0
South Eastern Sydney Area Health Service In Kind Support
Country [1] 319878 0
Australia
Primary sponsor type
Government body
Name
South Eastern Sydney Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 322407 0
None
Name [1] 322407 0
Address [1] 322407 0
Country [1] 322407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318430 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 318430 0
Ethics committee country [1] 318430 0
Australia
Date submitted for ethics approval [1] 318430 0
05/08/2025
Approval date [1] 318430 0
04/09/2025
Ethics approval number [1] 318430 0
2025/ETH01229

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

Contacts
Principal investigator
Name 144166 0
Mr Benjamin Wood
Address 144166 0
St George Hospital, 28 Gray St, Kogarah. 2217 NSW
Country 144166 0
Australia
Phone 144166 0
+61 456 923 943
Fax 144166 0
Email 144166 0
[email protected]
Contact person for public queries
Name 144167 0
Benjamin Wood
Address 144167 0
St George Hospital, 28 Gray St, Kogarah 2217 NSW
Country 144167 0
Australia
Phone 144167 0
+61 456 923 943
Fax 144167 0
Email 144167 0
[email protected]
Contact person for scientific queries
Name 144168 0
Benjamin Wood
Address 144168 0
St George Hospital, 28 Gray St, Kogarah 2217 NSW
Country 144168 0
Australia
Phone 144168 0
+61291132387
Fax 144168 0
Email 144168 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?



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.