- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07591974
Simulation-Based Training on Immediate Newborn Care (SBT-Newborn)
Effectiveness of Newborn Simulation-Based Training on Self Efficacy and Practices of Midwives in Immediate Newborn Care
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amal F Noori, PhD student (Nursing)
- Phone Number: 9647800082561
- Email: Aamal.Fadel2403p@conursing.uobaghdad.edu.iq
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Active work in the delivery room or emergency wards
- Direct involvement in labor, delivery, or immediate neonatal care.
- Minimum of one year of experience in maternity care
- No advanced immediate newborn care training in the past year
Exclusion Criteria:
- Less than one year of maternity care experience
- Participation in advanced immediate newborn care courses within the past
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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