NCT07373665

Brief Summary

This study examined the effect of a problem-based learning (PBL) instructional approach on undergraduate nursing students' learning outcomes in obstetrics health nursing. The intervention was implemented with nursing students at the Faculty of Nursing, Benha University, Egypt. Students participated in structured problem-based learning sessions designed to enhance critical thinking, clinical decision making, and knowledge retention related to maternal and newborn health topics. Learning outcomes were assessed before and after the intervention using validated assessment tools. The findings of this study aim to provide evidence on the effectiveness of problem-based learning as an educational strategy in nursing education and to inform curriculum development and teaching practices in obstetrics health nursing Course.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 21, 2026

Last Update Submit

January 21, 2026

Conditions

Keywords

Problem-based learningNursing educationObstetric nursingCritical thinkingClinical decision makingKnowledge retentionUndergraduate nursing studentsEducational interventionCluster randomized trial

Outcome Measures

Primary Outcomes (3)

  • Critical Thinking Skills

    Critical thinking skills were assessed using the Critical Thinking Questionnaire (CThQ), a validated 25-item self-administered instrument measuring six domains of critical thinking: remembering, understanding, applying, analyzing, evaluating, and creating. Items are rated on a 5-point Likert scale, with higher scores indicating stronger critical thinking ability.

    Baseline (pre-intervention), immediately post-intervention, and 4-week follow-up

  • Clinical Decision-Making Ability

    Clinical decision-making ability was measured using the Clinical Decision Making in Nursing Scale (CDMNS), a validated 40-item self-report instrument assessing four dimensions of decision-making: search for alternatives, canvassing of objectives and values, evaluation of consequences, and information search. Higher total scores reflect more developed clinical decision-making abilities.

    Baseline (pre-intervention), immediately post-intervention, and 4-week follow-up

  • Knowledge retention in obstetrics Health Nursing

    Knowledge acquisition and retention were assessed using a researcher-developed, case-based multiple-choice questionnaire covering normal labor, preeclampsia/eclampsia, and postpartum hemorrhage. The tool consists of 30 items, with higher scores indicating higher levels of knowledge acquisition and retention.

    Baseline (pre-intervention), immediately post-intervention, and 4-week follow-up

Study Arms (2)

Problem-Based Learning (PBL) Group

EXPERIMENTAL

Participants in this arm received a structured problem-based learning (PBL) instructional program covering normal labor, preeclampsia/eclampsia, and postpartum hemorrhage. The intervention was delivered in small-group sessions using standardized clinical case scenarios, guided facilitation, self-directed learning, and group discussion over a six-week period.

Behavioral: Problem-Based Learning (PBL)

Traditional Lecture-Based Instruction Group

ACTIVE COMPARATOR

Participants in this arm received traditional lecture-based instruction covering normal labor, preeclampsia/eclampsia, and postpartum hemorrhage, delivered through instructor-led lectures and PowerPoint presentations in accordance with the standard course syllabus.

Behavioral: Traditional Lecture-Based Instruction

Interventions

A structured problem-based learning instructional approach using standardized clinical case scenarios related to maternal and newborn health nursing. The intervention emphasized active learning, small-group discussion, self-directed learning, clinical reasoning, and facilitated synthesis of evidence-based nursing decisions. Arm Assigned:Problem-Based Learning (PBL) Group

Problem-Based Learning (PBL) Group

Traditional lecture-based instruction delivered through instructor-led teaching and PowerPoint presentations, covering maternal and newborn health nursing topics according to the standard undergraduate nursing curriculum. Arm Assigned:Traditional Lecture-Based Instruction Group

Traditional Lecture-Based Instruction Group

Eligibility Criteria

Age18 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Undergraduate nursing students enrolled in the third academic level of the Obstetrics and Gynecology Nursing course at the Faculty of Nursing, Benha University.
  • Aged 18 to 21 years at the time of enrollment.
  • Regular attendance in the course during the study period.
  • Willingness to participate and provide written informed consent.
  • No prior formal exposure to structured problem-based learning (PBL).
  • Completion of baseline assessment prior to participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Benha University

Banhā, Qalyubia Governorate, Egypt

Location

Study Officials

  • Eman Atef Elsokary, PhD

    Faculty of Nursing, Helwan University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This was an open-label educational intervention. Due to the nature of the instructional methods, participants, instructors, and investigators were aware of group allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were assigned to intervention or control groups using cluster randomization at the academic-group level to minimize contamination. Academic clusters were allocated in parallel to either problem-based learning (PBL) or traditional lecture-based instruction. All clusters were followed concurrently, and outcomes were assessed at baseline, immediately post-intervention, and at four-week follow-up.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Maternal and Newborn Health Nursing

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 28, 2026

Study Start

September 20, 2025

Primary Completion

December 25, 2025

Study Completion

January 20, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations