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.
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
- Conditions the study is for
- Maternity Nursing, Obstetric Nursing, Clinical Competence
- What is being tested?
- Structured Scenario-Based Clinical Teaching in Maternity Care
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| male nursing students cohort | Experimental | Single 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.
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)
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)
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.
- First posted26 Oct 2026
- Study start1 Oct 2026
- Primary completion23 Jan 2027 (estimated)
- Study completion23 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternity NursingStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Male Nursing Students' Competence in Maternity Care: A Quasi-Experimental Study in Egypt
- ClinicalTrials.gov ID
- NCT07894419
- Acronym / sponsor ID
- DFM-IRB00012367
- Keywords
- Scenario-Based Learning, OSCE, Maternity Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 23 Jan 2027 (estimated)
- Study completion
- 23 Jan 2027 (estimated)
- First posted
- 26 Oct 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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one group pre test post test quasi experimental design
| Arm | Type | Receives |
|---|---|---|
| male nursing students cohort | Experimental | Behavioral: Structured Scenario-Based Clinical Teaching in Maternity CareSingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Structured Scenario-Based Clinical Teaching in Maternity CareA 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 | Behavioural | male nursing students cohort |
Primary outcome
Change in Objective Structured Clinical Examination (OSCE) Total Score
Time frame: Baseline (pre-test) and immediately following the educational intervention (post-test)
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.
2 secondary outcomes
Change in Student Satisfaction and Self-Confidence in Learning Scores
Time frame: Baseline (pre-test) and immediately following the educational intervention (post-test)
Change in Practical Performance Checklist Scores
Time frame: Baseline (pre-test) and immediately following the educational intervention (post-test)
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 27 Oct 2026.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.