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Maternity NursingNCT07894419

Enhancing Male Nursing Students' Competence in Maternity Care: A Quasi-Experimental Study in Egypt

A study testing Structured Scenario-Based Clinical Teaching in Maternity Care in people with Maternity Nursing and Obstetric Nursing, run by Delta University for Science and Technology at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary aim of this study is to evaluate the effect of structured clinical teaching scenarios on male nursing students' competence-including knowledge, self-confidence, and practical performance-in maternity care. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
What is being tested?
Structured Scenario-Based Clinical Teaching in Maternity Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteEgypt
Study dates
1 Oct 2026to 23 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 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Inclusion Criteria:Enrolled as a male undergraduate nursing student in the maternity nursing clinical course at the Faculty of Nursing, Delta University for Science and Technology during the academic year of data collection.

Voluntary agreement to participate in the study with signed written informed consent.

Regular attendance in required clinical and simulation course sessions. -

Exclusion Criteria:Absence during either the pre-test or post-test evaluation sessions.

Refusal to participate or withdrawal of consent at any point during the study period.

Prior formal or advanced simulation-based maternity nursing training outside the regular university undergraduate curriculum.

-

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Delta university for science and technology

    Gamasa, Dakahlia Governorate, 35712

Other trials in Egypt

About this study

The primary aim of this study is to evaluate the effect of structured clinical teaching scenarios on male nursing students' competence-including knowledge, self-confidence, and practical performance-in maternity care.

In many countries, including Egypt, male nursing students face significant barriers during obstetric and gynecological clinical rotations due to cultural beliefs, patient preferences, and traditional gender perceptions. These limitations restrict opportunities for direct hands-on practice, which can negatively affect students' clinical confidence and procedural skills.

To address these educational gaps, this quasi-experimental study utilizes a one-group pre-test/post-test design. A total of 150 male undergraduate nursing students enrolled in the maternity nursing clinical course at Delta University for Science and Technology, Egypt, will participate in structured scenario-based clinical teaching and simulation training. Clinical competence, practical skills, self-confidence, and learning satisfaction will be assessed before and immediately after the educational intervention using an Objective Structured Clinical Examination (OSCE), standardized performance checklists, and validated satisfaction and confidence scales.

Read the detailed description

Maternity nursing requires advanced clinical competence, rapid decision-making, effective communication, and patient-centered care. While nursing education globally is shifting toward competency-based learning, male nursing students face considerable cultural and institutional restrictions during maternity clinical training. In Egypt, approximately 240 male nursing students enroll annually in maternity clinical courses at Delta University, with many reporting difficulty in obtaining direct patient contact during hospital rotations. Structured scenario-based clinical teaching and simulation training offer a safe, controlled environment where students can repeatedly practice essential obstetric and gynecological nursing skills without compromising patient comfort or safety.

Objectives Assess male nursing students' baseline knowledge, practical performance, and self-confidence in maternity nursing care prior to the intervention.

Implement a structured, scenario-based maternity nursing educational program using realistic simulation scenarios.

Evaluate changes in male nursing students' knowledge, procedural competence, self-confidence, and satisfaction following the implementation of the simulation scenarios.

Study Design \& Procedures Design: Quasi-experimental, single-group pre-test and post-test design (O_1 \rightarrow X \rightarrow O_2).

Setting: Faculty of Nursing, Delta University for Science and Technology, Egypt.

Sample: 150 male undergraduate nursing students selected via non-probability purposive sampling.

Intervention

Participants will complete a series of structured, scenario-based clinical teaching and simulation sessions. Scenarios cover core maternity nursing competencies and emergency situations, including:

Abdominal and vaginal examination procedures Partograph interpretation and expected date of delivery (EDD) calculation Edema grading and deep tendon reflex assessment Perineal, episiotomy, and nipple care Uterine massage and placenta examination Identification of obstetric instruments and emergency maternity interventions Each simulation session includes pre-briefing, active scenario management, and instructor-guided debriefing/reflection.

Outcome Measurement \& Instrumentation

Data collection occurs at baseline (pre-intervention) and immediately post-intervention using three validated instruments:

Adapted Simulation Design and Student Satisfaction Scale (OB/GYN): A 44-item instrument utilizing a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree) to assess satisfaction with learning, self-confidence, simulation design quality, and educational practices.

Objective Structured Clinical Examination (OSCE): A 20-station examination assessing clinical reasoning, interpretation, and decision-making skills. Each station is allocated 5 minutes and scored against standardized model answer keys (total score converted to a mean percentage).

Performance Checklists: Observational checklists using a 3-point rating scale (0 = \text{Not performed}, 1 = \text{Performed with assistance}, 2 = \text{Performed correctly}) to evaluate direct procedural accuracy during core maternity nursing skills.

Being tested
Structured Scenario-Based Clinical Teaching in Maternity Care
Keywords
Scenario-Based Learning, OSCE, Maternity Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured Scenario-Based Clinical Teaching in Maternity CareBehavioural

    A structured educational program comprising simulation scenarios across core maternity nursing competencies (e.g., abdominal/vaginal exams, partograph interpretation, edema/deep tendon reflex assessment, episiotomy/perineal care, and obstetric emergency management). Each session includes pre-briefing, active scenario execution, and instructor-guided debriefing

Study groups in NCT07894419
Study groupRoleWhat they receive
male nursing students cohortExperimentalSingle experimental group consisting of 150 male undergraduate nursing students enrolled in the maternity clinical course. All participants receive the structured scenario-based clinical teaching and simulation intervention following baseline (pre-test) assessments.
Receives: Behavioral: Structured Scenario-Based Clinical Teaching in Maternity Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Objective Structured Clinical Examination (OSCE) Total Score

    Evaluates clinical competence and practical performance across 20 structured examination stations covering obstetric and gynecological nursing skills, clinical calculations, partograph interpretation, and maternity-related interventions. Scored as a mean percentage ranging from 0% to 100%, where higher percentages indicate greater clinical competence, procedural accuracy, and practical performance.

    Measured: Baseline (pre-test) and immediately following the educational intervention (post-test)

Secondary outcomes (2)
  1. Change in Student Satisfaction and Self-Confidence in Learning Scores

    Assessed using the adapted Student Satisfaction and Self-Confidence in Learning Scale (SSSCL) and adapted Simulation Design Scale. Measured on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Higher total scores indicate higher student satisfaction with learning, increased self-confidence in maternity care, and more positive perceptions of simulation design.

    Measured: Baseline (pre-test) and immediately following the educational intervention (post-test)

  2. Change in Practical Performance Checklist Scores

    Evaluates procedural competency and accuracy across core maternity nursing skills (such as edema assessment, deep tendon reflex assessment, perineal care, episiotomy care, abdominal and vaginal examinations, and partograph assessment) using a structured observational checklist. Scored on a 3-point rating scale (0 = \text{Not performed}, 1 = \text{Performed with assistance}, 2 = \text{Performed correctly}), converted to a total percentage score. Higher scores indicate better procedural competency and independent performance.

    Measured: Baseline (pre-test) and immediately following the educational intervention (post-test)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study start1 Oct 2026
  3. Primary completion23 Jan 2027 (estimated)
  4. Study completion23 Jan 2027 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
one group pre test post test quasi experimental design
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07894419
Sponsor's protocol ID
DFM-IRB00012367
Status last verified
May 2026
First submitted
19 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data collected during this study will not be made publicly available to protect participant privacy and maintain confidentiality in accordance with institutional ethics guidelines and the approved study protocol. Aggregate statistical data, mean scores, and study findings will be made available through academic publications and conference presentations.

Questions about this trial

What is this clinical trial studying?

A study testing Structured Scenario-Based Clinical Teaching in Maternity Care in people with Maternity Nursing and Obstetric Nursing, run by Delta University for Science and Technology at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Objective Structured Clinical Examination (OSCE) Total Score (time frame: Baseline (pre-test) and immediately following the educational intervention (post-test)). 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 27 Oct 2026.

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