Simulation-Based Training on Immediate Newborn Care (SBT-Newborn)

May 14, 2026 updated by: Amal Fadhil Noori Radi, University of Baghdad

Effectiveness of Newborn Simulation-Based Training on Self Efficacy and Practices of Midwives in Immediate Newborn Care

This study aims to evaluate the effectiveness of simulation-based training on improving self-efficacy and clinical practices of midwives in providing immediate newborn care. It is a quasi-experimental study conducted among midwives working in healthcare settings to assess the impact of training on their knowledge, confidence, and practical performance in newborn care immediately after delivery.

Study Overview

Detailed Description

This study aims to assess the effectiveness of simulation-based training on improving self-efficacy and clinical practices of midwives in providing immediate newborn care. Immediate newborn care is a critical component in reducing neonatal morbidity and mortality, and adequate preparation of midwives plays a key role in ensuring safe and effective care.

A quasi-experimental design will be used to conduct this study among midwives working in selected healthcare facilities in Iraq. The participants will be divided into a study group and a control group. The study group will receive structured simulation-based training sessions focused on immediate newborn care, while the control group will continue with routine practice without intervention.

Data will be collected using a validated self-efficacy questionnaire and an observational checklist to assess clinical practices before and after the intervention. Pre- and post-intervention comparisons will be conducted to evaluate the effectiveness of the training program.

The expected outcome of this study is to improve midwives' self-efficacy and enhance their practical skills in immediate newborn care, ultimately contributing to better neonatal health outcomes.

Study Type

Interventional

Enrollment (Estimated)

100

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Active work in the delivery room or emergency wards
  2. Direct involvement in labor, delivery, or immediate neonatal care.
  3. Minimum of one year of experience in maternity care
  4. No advanced immediate newborn care training in the past year

Exclusion Criteria:

  1. Less than one year of maternity care experience
  2. Participation in advanced immediate newborn care courses within the past

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Participants in this group will receive simulation-based training on immediate newborn care. The training includes structured practical sessions using simulation scenarios designed to improve clinical skills, self-efficacy, and performance in newborn care immediately after delivery.
A structured simulation-based training designed to improve midwives' self-efficacy, and clinical practice in immediate newborn care.
No Intervention: control group
Participants in this group will continue with routine clinical practice without receiving simulation-based training during the study period. They will not be exposed to the structured training intervention and will serve as a comparison group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-efficacy of midwives in immediate newborncare
Time Frame: Baseline and immediately after simulation-based training
Measured using a validated self-efficacy questionnaire to assess midwives' confidence in performing immediate newborn care procedures before and after the simulation-based training intervention
Baseline and immediately after simulation-based training
Midwives' self-efficacy and practice scores regarding immediate newborn care
Time Frame: Baseline and immediately after simulation-based training
Assessment of midwives' self-efficacy and clinical practice regarding immediate newborn care following simulation-based training using a structured questionnaire and observational checklist. Higher scores indicate better self-efficacy and improved practice.
Baseline and immediately after simulation-based training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
practice in immediate newborn care
Time Frame: Baseline and immediately after simulation-based training
Measured using observational checklist evaluating midwives' performance immediate newborn care procedures before and after the simulation-based training intervention.
Baseline and immediately after simulation-based training

Collaborators and Investigators

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

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

May 9, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SBT on immediate newborn care

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly. The collected data will remain confidential and will be used only by the research team for analysis and publication purposes. Data will be stored securely and anonymized to protect participants' privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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