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

June 9, 2025 updated by: The University of Hong Kong

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
    • Hksar
      • Hong Kong, Hksar, Hong Kong
        • Recruiting
        • Hong Kong Metropolitan University
        • Contact:
        • Principal Investigator:
          • Wai Ming CHUNG, MNur
        • Sub-Investigator:
          • Po Man Lee, DNur
        • Sub-Investigator:
          • Hoi Ki Yeung, MNur
        • Sub-Investigator:
          • Kit Wah Wong, MNur
        • Sub-Investigator:
          • Yuet Wan Lok, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group with HFS baby

For intervention group, the high fidelity simulation session will be arranged earlier.

.
Behavioral: high fidelity simulation-based training

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.

Behavioral: conventional training
Conventional training includes lecture, tutorial and basic lab with low-fidelity mannequins.
Other: Control group with conventional
For control group, they will undergo convention training. An identical simulation session will be provided for the control group after completion of the study
Behavioral: conventional training
Conventional training includes lecture, tutorial and basic lab with low-fidelity mannequins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

  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).
5min
Level of knowledge and skill in caring for newborn baby and breastfeeding
Time Frame: 4min

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).
4min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  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).
3min
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:

  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).
3min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Questionnaire
Time Frame: 2min
sociodemographic baseline
2min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Wai Ming CHUNG, HKU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HFSBLBF1224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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