NCT07591974

Brief 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, confidence, and practical performance in newborn care immediately after delivery.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 9, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

Simulation- based training, midwives, immediate newborn care, self efficacy

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Baseline and immediately after simulation-based training

Secondary Outcomes (1)

  • practice in immediate newborn care

    Baseline and immediately after simulation-based training

Study Arms (2)

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.

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.

Interventions

A structured simulation-based training designed to improve midwives' self-efficacy, and clinical practice in immediate newborn care.

intervention group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale only
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Amal F Noori, PhD student (Nursing)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study with no masking because participants receive a simulation-based training intervention that cannot be blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student, Collage of Nursing, University of Baghdad

Study Record Dates

First Submitted

May 9, 2026

First Posted

May 18, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.