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NCT Number: NCT06722248

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

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

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Key information

Conditions

High Fidelity Simulation Training Behavior Breast Feeding Feeding Behavior

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Metropolitan University

Hong Kong, Hksar

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Nil

Treatment and study plan

high fidelity simulation-based training

Behavioral

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 training

Behavioral

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

Primary outcomes

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

    Time frame: 5min

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

    • - Very simple for me to do
    • - Easy for me to do
    • - Difficult for me to do
    • - 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).

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

    Time frame: 4min

    20 items

    • True
    • May be true
    • 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).

Secondary outcomes

  1. Simulation Design Scale (SDS)

    Time frame: 3min

    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:

    • - Strongly Disagree with the statement
    • - Disagree with the statement
    • - Undecided - you neither agree or disagree with the statement
    • - Agree with the statement
    • - 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.

    • - Not Important
    • - Somewhat Important
    • - Neutral
    • - Important
    • - Very Important

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

  2. Education Practices Questionnaire (EPS)

    Time frame: 3min

    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:

    • - Strongly Disagree with the statement
    • - Disagree with the statement
    • - Undecided - you neither agree or disagree with the statement
    • - Agree with the statement
    • - 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.

    • - Not Important
    • - Somewhat Important
    • - Neutral
    • - Important
    • - Very Important

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

Other outcomes

  1. Demographic Questionnaire

    Time frame: 2min

    sociodemographic baseline

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Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 9, 2024
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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