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High Fidelity Simulation TrainingNCT06722248

High Fidelity Simulation-based Learning Approach in Maternal and Infant Care

A study testing high fidelity simulation-based training and conventional training in people with High Fidelity Simulation Training, run by The University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Study type: clinical trial - randomized control trial Primary purpose: to explore the effectiveness of high-fidelity simulation (HFS) interventions, specifically scenario-based training with pre-briefing and de-briefing on (1) knowledge and self-efficacy (2) problem solving abilities, (3) the learning experience among… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
High Fidelity Simulation Training
What is being tested?
high fidelity simulation-based training and conventional training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteHong Kong
Study dates
1 Mar 2025to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • undergraduate nursing students
  • newly enrolled obstetric course
  • can provide consent for simulation confidentiality
  • do not have previous clinical experience or training in obstetrical units

Who cannot join

  • Nil

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wai Ming CHUNG contact

69796719

h0394197@connect.hku.hk

Yuet Wan Lok, Dr contact

31976690

krislok@hku.hk

Hong Kong1 site, 1 recruiting
  • Hong Kong Metropolitan University

    Hong Kong, Hksar

    Wai Ming Chung, MNur, +852-69796719, rwmchung@hkmu.edu.hk

    Wai Ming CHUNG, MNur

    Recruiting

Other trials in Hong Kong

About this study

Official title: Exploring Nursing Students' Experience and Attitudes Towards High Fidelity Simulation-based Learning Approach in Maternal and Infant Care: A Mixed Method Study

Study type: clinical trial - randomized control trial Primary purpose: to explore the effectiveness of high-fidelity simulation (HFS) interventions, specifically scenario-based training with pre-briefing and de-briefing on (1) knowledge and self-efficacy (2) problem solving abilities, (3) the learning experience among nursing students in baby care and breastfeeding, as compared to traditional training.

Primary outcome: breastfeeding self-efficacy scores and knowledge in the intervention compared to the control group Secondary outcome: Simulation Design Scale and Education Practices Questionnaire

Read the detailed description

Background and Rationale of Study:

Nursing students commonly reported feeling unprepared in maternity and infant care clinical setting or lack competencies. Additionally, nurses are concerned about the clinical reasoning skills of new graduates, which may lead to poor quality of infants or maternal outcomes. Despite this importance, it is difficult to provide more clinical opportunities especially during COVID pandemics. High-fidelity simulation-based learning (HFS) can help to bridge the gap between theory and practice, with manikin citing the similarities to practice in a 'real' situation. By incorporating different scenarios, prebriefing and debriefing into the HFS, students can enhance their learning experience. However, there is a lack of studies specifically examining the use of HFS in baby care and breastfeeding among nursing students. The impact of HFS on learning outcomes, including knowledge and skills, problem solving abilities, and learning experience are unclear.

Being tested
high fidelity simulation-based training, conventional training
Keywords
"simulation training", "high fidelity", "infant care", "breastfeeding", "nursing student"
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high fidelity simulation-based trainingBehavioural

    The intervention is a two-hour high-fidelity simulation training session focusing on newborn assessment, care practices, skin-to-skin contact, and breastfeeding. It uses SimBaby mannequins and breastfeeding models to mimic the hospital environment. Scenarios are tailored to nursing students' learning levels and reviewed by experienced midwives.

    The training includes:

    Prebriefing: Introduction of learning objectives, scenario background, simulation familiarization, confidentiality discussions, and ground rules.

    Intervention: Scenario-based training on baby care and breastfeeding. Debriefing: Plus-delta debriefing model reviewed by simulation educators. The training will be conducted in the nursing simulation laboratory.

  • conventional trainingBehavioural

    Conventional training includes lecture, tutorial and basic lab with low-fidelity mannequins.

Study groups in NCT06722248
Study groupRoleWhat they receive
Intervention group with HFS babyExperimentalFor intervention group, the high fidelity simulation session will be arranged earlier. .
Receives: Behavioral: high fidelity simulation-based training; Behavioral: conventional training
Control group with conventionalOtherFor control group, they will undergo convention training. An identical simulation session will be provided for the control group after completion of the study
Receives: Behavioral: conventional training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self efficacy on basic breastfeeding knowledge and skills with a self-rated breastfeeding ability tool

    37-items modified version was designed to estimate self-efficacy in performing tasks of different complexity, relating to breastfeeding support

    1. - Very simple for me to do
    2. - Easy for me to do
    3. - Difficult for me to do
    4. - Very hard for me to do

    For each question: minimum value = 1 and maximum value = 4 The higher scores mean a worst outcome (lower self efficacy).

    Measured: 5min

  2. Level of knowledge and skill in caring for newborn baby and breastfeeding

    20 items

    1. True
    2. May be true
    3. I dont know 4 = May be false 5 = False (for correct answer: 5 marks per questions, max total: 100) (for wrong answer: -5 marks per questions, min total: -100) (for may be: 2 to -2 marks; for i dont know: 0 marks)

    For each question: minimum value = -5 and maximum value = 5 The higher scores mean a better outcome (better knowledge).

    Measured: 4min

Secondary outcomes (2)
  1. Simulation Design Scale (SDS)

    20 items and is used to evaluate simulation training design from the learners' perspective. The scale assesses various aspects such as objective, information, support, problem solving, feedback and fidelity in simulation

    Use the following rating system when assessing the simulation design elements:

    1. - Strongly Disagree with the statement
    2. - Disagree with the statement
    3. - Undecided - you neither agree or disagree with the statement
    4. - Agree with the statement
    5. - Strongly Agree with the statement NA - Not Applicable; the statement does not pertain to the simulation activity performed.

    For each question: minimum value = 1 and maximum value = 5 The higher scores mean a better outcome (better design).

    Rate each item based upon how important that item is to you.

    1. - Not Important
    2. - Somewhat Important
    3. - Neutral
    4. - Important
    5. - Very Important

    For each question: minimum value = 1 and maximum value = 5 The higher scores mean a better outcome (more important).

    Measured: 3min

  2. Education Practices Questionnaire (EPS)

    16 items and is used to access perceptions of education best practices' presence and importance in simulation training

    Use the following rating system when assessing the simulation design elements:

    1. - Strongly Disagree with the statement
    2. - Disagree with the statement
    3. - Undecided - you neither agree or disagree with the statement
    4. - Agree with the statement
    5. - Strongly Agree with the statement NA - Not Applicable; the statement does not pertain to the simulation activity performed.

    For each question: minimum value = 1 and maximum value = 5 The higher scores mean a better outcome (better learning experience).

    Rate each item based upon how important that item is to you.

    1. - Not Important
    2. - Somewhat Important
    3. - Neutral
    4. - Important
    5. - Very Important

    For each question: minimum value = 1 and maximum value = 5 The higher scores mean a better outcome (more important).

    Measured: 3min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2024
  2. Study start1 Mar 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Block randomization with random block size 4, 6 will be used to allocate participants into intervention or control group using a online block randomization list generator
Masking
Single blind
Who is masked
Participant
Enrolment
158 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06722248
Sponsor's protocol ID
HFSBLBF1224
Status last verified
Dec 2024
First submitted
5 Dec 2024
Last updated
11 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Akalin A, Sahin S. The impact of high-fidelity simulation on knowledge, critical thinking, and clinical decision-making for the management of pre-eclampsia. Int J Gynaecol Obstet. 2020 Sep;150(3):354-360. doi: 10.1002/ijgo.13243. Epub 2020 Jun 21.

    PubMed 32469084
  • Anderson OS, Weirauch K, Roper R, Phillips J, McCabe C, Chuisano SA, Sadovnikova A. The Efficacy of Hybrid Telesimulation with Standardized Patients in Teaching Medical Students Clinical Lactation Skills: A Pilot Study. Breastfeed Med. 2021 Apr;16(4):332-337. doi: 10.1089/bfm.2020.0253. Epub 2021 Jan 25.

    PubMed 33493401
  • Alshehri FD, Jones S, Harrison D. The effectiveness of high-fidelity simulation on undergraduate nursing students' clinical reasoning-related skills: A systematic review. Nurse Educ Today. 2023 Feb;121:105679. doi: 10.1016/j.nedt.2022.105679. Epub 2022 Dec 5.

    PubMed 36542870
  • Au ML, Tong LK, Li YY, Ng WI, Wang SC. Impact of scenario validity and group size on learning outcomes in high-fidelity simulation: A systematics review and meta-analysis. Nurse Educ Today. 2023 Feb;121:105705. doi: 10.1016/j.nedt.2022.105705. Epub 2022 Dec 30.

    PubMed 36599250
  • Blackman I, Sweet L, Byrne J. Using Rasch analysis to identify midwifery students' learning about providing breastfeeding support. Women Birth. 2015 Sep;28(3):228-35. doi: 10.1016/j.wombi.2015.02.001. Epub 2015 Mar 6.

    PubMed 25754763
  • Cheng A, Grant V, Dieckmann P, Arora S, Robinson T, Eppich W. Faculty Development for Simulation Programs: Five Issues for the Future of Debriefing Training. Simul Healthc. 2015 Aug;10(4):217-22. doi: 10.1097/SIH.0000000000000090.

    PubMed 26098492
  • Cobbett S, Snelgrove-Clarke E. Virtual versus face-to-face clinical simulation in relation to student knowledge, anxiety, and self-confidence in maternal-newborn nursing: A randomized controlled trial. Nurse Educ Today. 2016 Oct;45:179-84. doi: 10.1016/j.nedt.2016.08.004. Epub 2016 Aug 9.

    PubMed 27537670
  • Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.

    PubMed 14649593
  • Eppich W, Cheng A. Promoting Excellence and Reflective Learning in Simulation (PEARLS): development and rationale for a blended approach to health care simulation debriefing. Simul Healthc. 2015 Apr;10(2):106-15. doi: 10.1097/SIH.0000000000000072.

    PubMed 25710312
  • Eppich WJ, Hunt EA, Duval-Arnould JM, Siddall VJ, Cheng A. Structuring feedback and debriefing to achieve mastery learning goals. Acad Med. 2015 Nov;90(11):1501-8. doi: 10.1097/ACM.0000000000000934.

    PubMed 26375272
  • Fan HSL, Fong DYT, Lok KYW, Tarrant M. The Association Between Breastfeeding Self-Efficacy and Mode of Infant Feeding. Breastfeed Med. 2022 Aug;17(8):687-697. doi: 10.1089/bfm.2022.0059. Epub 2022 Jun 28.

    PubMed 35763837
  • Fanning RM, Gaba DM. The role of debriefing in simulation-based learning. Simul Healthc. 2007 Summer;2(2):115-25. doi: 10.1097/SIH.0b013e3180315539. No abstract available.

    PubMed 19088616
  • Franklin AE, Burns P, Lee CS. Psychometric testing on the NLN Student Satisfaction and Self-Confidence in Learning, Simulation Design Scale, and Educational Practices Questionnaire using a sample of pre-licensure novice nurses. Nurse Educ Today. 2014 Oct;34(10):1298-304. doi: 10.1016/j.nedt.2014.06.011. Epub 2014 Jul 9.

    PubMed 25066650
  • Gozali A, Gibson S, Lipton LR, Pressman AW, Hammond BS, Dumitriu D. Assessing the effectiveness of a pediatrician-led newborn parenting class on maternal newborn-care knowledge, confidence and anxiety: A quasi-randomized controlled trial. Early Hum Dev. 2020 Aug;147:105082. doi: 10.1016/j.earlhumdev.2020.105082. Epub 2020 May 23.

    PubMed 32512498
  • Grabowski A, Chuisano SA, Strock K, Zielinski R, Anderson OS, Sadovnikova A. A pilot study to evaluate the effect of classroom-based high-fidelity simulation on midwifery students' self-efficacy in clinical lactation and perceived translation of skills to the care of the breastfeeding mother-infant dyad. Midwifery. 2021 Nov;102:103078. doi: 10.1016/j.midw.2021.103078. Epub 2021 Jun 30.

    PubMed 34271343

Questions about this trial

What is this clinical trial studying?

A study testing high fidelity simulation-based training and conventional training in people with High Fidelity Simulation Training, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wai Ming CHUNG (69796719, h0394197@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self efficacy on basic breastfeeding knowledge and skills with a self-rated breastfeeding ability tool (time frame: 5min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06722248, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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