Newborn CareSBT-NewbornNCT07591974
Simulation-Based Training on Immediate Newborn Care
A study testing participants receive simulation-based training on immediate newborn care. The training includes structured practical sessions using simulation scenarios designed to improve practce in people with Newborn Care, run by University of Baghdad.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Newborn Care
- What is being tested?
- participants receive simulation-based training on immediate newborn care. The training includes structured practical sessions using simulation scenarios designed to improve practce
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Jan 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than one year of maternity care experience
- Participation in advanced immediate newborn care courses within the past
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Newborn Care
- Being tested
- participants receive simulation-based training on immediate newborn care. The training includes structured practical sessions using simulation scenarios designed to improve practce
- Keywords
- Simulation- based training, midwives, immediate newborn care, self efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participants receive simulation-based training on immediate newborn care. The training includes structured practical sessions using simulation scenarios designed to improve practceProcedure or surgery
A structured simulation-based training designed to improve midwives' self-efficacy, and clinical practice in immediate newborn care.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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. Receives: Procedure: participants receive simulation-based training on immediate newborn care. The training includes structured practical sessions using simulation scenarios designed to improve practce |
| control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
self-efficacy of midwives in immediate newborncare
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
Measured: Baseline and immediately after simulation-based training
Midwives' self-efficacy and practice scores regarding immediate newborn care
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.
Measured: Baseline and immediately after simulation-based training
Secondary outcomes (1)
practice in immediate newborn care
Measured using observational checklist evaluating midwives' performance immediate newborn care procedures before and after the simulation-based training intervention.
Measured: Baseline and immediately after simulation-based training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a quasi-experimental study with a parallel group design. Participants will be assigned into an intervention group and a control group. The intervention group will receive simulation-based training on immediate newborn care, while the control group will continue with routine practice. Outcomes will be assessed before and after the intervention to evaluate changes in self-efficacy and clinical practice.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Fadhil Noori Radi, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591974
- Sponsor's protocol ID
- SBT on immediate newborn care
- Acronym
- SBT-Newborn
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Newborn Simulation-Based Training on Self Efficacy and Practices of Midwives in Immediate Newborn Care
- ClinicalTrials.gov ID
- NCT07591974
- Acronym / sponsor ID
- SBT-Newborn / SBT on immediate newborn care
- Conditions
- Newborn Care
- Keywords
- Simulation- based training, midwives, immediate newborn care, self efficacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a quasi-experimental study with a parallel group design. Participants will be assigned into an intervention group and a control group. The intervention group will receive simulation-based training on immediate newborn care, while the control group will continue with routine practice. Outcomes will be assessed before and after the intervention to evaluate changes in self-efficacy and clinical practice.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: participants receive simulation-based training on immediate newborn care. The training includes structured practical sessions using simulation scenarios designed to improve practceParticipants 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. |
| control group | No intervention | –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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Less than one year of maternity care experience
- Participation in advanced immediate newborn care courses within the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| participants receive simulation-based training on immediate newborn care. The training includes structured practical sessions using simulation scenarios designed to improve practceA structured simulation-based training designed to improve midwives' self-efficacy, and clinical practice in immediate newborn care. | Procedure or surgery | intervention group |
Primary outcome
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
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.
1 secondary outcome
practice in immediate newborn care
Time frame: Baseline and immediately after simulation-based training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing participants receive simulation-based training on immediate newborn care. The training includes structured practical sessions using simulation scenarios designed to improve practce in people with Newborn Care, run by University of Baghdad.
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 2 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: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Amal F Noori, PhD student (Nursing) (9647800082561, Aamal.Fadel2403p@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-efficacy of midwives in immediate newborncare (time frame: Baseline and immediately after simulation-based training). 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?
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 18 May 2026.