Problem-based Learning in Nursing EducationNCT07373665
Problem-Based Learning to Improve Critical Thinking in Obstetric Nursing Students
A study testing Problem-Based Learning (PBL) and Traditional Lecture-Based Instruction in people with Problem-based Learning in Nursing Education, run by Eman Atef Elsokary at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Problem-based Learning in Nursing Education
- What is being tested?
- Problem-Based Learning (PBL) and Traditional Lecture-Based Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Critical Thinking, Clinical Decision-Making, and Knowledge Retention Utilizing Problem-Based Learning: A Cluster Randomized Controlled Trial Among Obstetric Nursing Students
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.
Read the detailed description
This study is a cluster randomized controlled trial designed to evaluate the effect of a problem-based learning (PBL) instructional approach on critical thinking, clinical decision-making, and knowledge acquisition and retention among undergraduate obstetric nursing students. The study was conducted in classroom settings at the Faculty of Nursing, Benha University, Benha, Egypt, during the first semester of the 2025-2026 academic year.
Eligible participants were third-level undergraduate nursing students enrolled in the obstetrics nursing course. Academic groups were used as the unit of randomization to minimize contamination between students. From the available academic groups, 12 clusters were randomly selected and allocated in a 1:1 ratio to either the intervention group (PBL) or the control group (traditional lecture-based instruction). All eligible students within the selected clusters were included, resulting in a total sample of 312 students.
At baseline, participants in both groups completed assessments measuring demographic characteristics, knowledge acquisition, critical thinking, and clinical decision-making. Following baseline assessment, control clusters received traditional lecture-based instruction covering normal labor, preeclampsia/eclampsia, and postpartum hemorrhage according to the standard course syllabus. Intervention clusters participated in a structured PBL program addressing the same topics using standardized clinical case scenarios and guided facilitation. The intervention emphasized problem identification, self-directed learning, group discussion, and application of knowledge to clinical decision-making.
Outcome measures were collected immediately after completion of the instructional period and again four weeks later to evaluate knowledge retention and sustained development of critical thinking and clinical decision-making skills. Validated instruments were used to assess critical thinking and clinical decision-making, while a researcher-developed, case-based multiple-choice questionnaire was used to assess knowledge acquisition and retention. Ethical approval was obtained from the Scientific Research Ethics Committee of the Faculty of Nursing, Helwan University prior to study initiation. Participation was voluntary, and informed consent was obtained from all participants.
- Being tested
- Problem-Based Learning (PBL), Traditional Lecture-Based Instruction
- Keywords
- Problem-based learning, Nursing education, Obstetric nursing, Critical thinking, Clinical decision making, Knowledge retention, Undergraduate nursing students, Educational intervention, Cluster randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Based Learning (PBL)Behavioural
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
Traditional Lecture-Based InstructionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional Lecture-Based Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention), immediately post-intervention, and 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start20 Sep 2025
- Primary completion25 Dec 2025
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem-based Learning in Nursing EducationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eman Atef Elsokary
- Sponsor type
- University, hospital or other
- Collaborators
- Helwan University
- Responsible party
- Sponsor-investigator, Eman Atef Elsokary, Benha University
- Investigators
- Eman Atef Elsokary, PhD, Principal investigator, Faculty of Nursing, Helwan University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373665
- Sponsor's protocol ID
- PBL-OBN-2025
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Critical Thinking, Clinical Decision-Making, and Knowledge Retention Utilizing Problem-Based Learning: A Cluster Randomized Controlled Trial Among Obstetric Nursing Students
- ClinicalTrials.gov ID
- NCT07373665
- Acronym / sponsor ID
- PBL-OBN-2025
- Keywords
- Problem-based learning, Nursing education, Obstetric nursing, Critical thinking, Clinical decision making, Knowledge retention, Undergraduate nursing students, Educational intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Eman Atef ElsokaryUniversity, hospital or other
- Collaborators
- Helwan University
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 28 Jan 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 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.
Detailed description
This study is a cluster randomized controlled trial designed to evaluate the effect of a problem-based learning (PBL) instructional approach on critical thinking, clinical decision-making, and knowledge acquisition and retention among undergraduate obstetric nursing students. The study was conducted in classroom settings at the Faculty of Nursing, Benha University, Benha, Egypt, during the first semester of the 2025-2026 academic year.
Eligible participants were third-level undergraduate nursing students enrolled in the obstetrics nursing course. Academic groups were used as the unit of randomization to minimize contamination between students. From the available academic groups, 12 clusters were randomly selected and allocated in a 1:1 ratio to either the intervention group (PBL) or the control group (traditional lecture-based instruction). All eligible students within the selected clusters were included, resulting in a total sample of 312 students.
At baseline, participants in both groups completed assessments measuring demographic characteristics, knowledge acquisition, critical thinking, and clinical decision-making. Following baseline assessment, control clusters received traditional lecture-based instruction covering normal labor, preeclampsia/eclampsia, and postpartum hemorrhage according to the standard course syllabus. Intervention clusters participated in a structured PBL program addressing the same topics using standardized clinical case scenarios and guided facilitation. The intervention emphasized problem identification, self-directed learning, group discussion, and application of knowledge to clinical decision-making.
Outcome measures were collected immediately after completion of the instructional period and again four weeks later to evaluate knowledge retention and sustained development of critical thinking and clinical decision-making skills. Validated instruments were used to assess critical thinking and clinical decision-making, while a researcher-developed, case-based multiple-choice questionnaire was used to assess knowledge acquisition and retention. Ethical approval was obtained from the Scientific Research Ethics Committee of the Faculty of Nursing, Helwan University prior to study initiation. Participation was voluntary, and informed consent was obtained from all participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Problem-Based Learning (PBL) Group | Experimental | Behavioral: Problem-Based Learning (PBL)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. |
| Traditional Lecture-Based Instruction Group | Active comparator | Behavioral: Traditional Lecture-Based InstructionParticipants 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. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Problem-Based Learning (PBL)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 | Behavioural | Problem-Based Learning (PBL) Group |
| Traditional Lecture-Based InstructionTraditional 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 | Behavioural | Traditional Lecture-Based Instruction Group |
Primary outcome
Critical Thinking Skills
Time frame: Baseline (pre-intervention), immediately post-intervention, and 4-week follow-up
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.
Clinical Decision-Making Ability
Time frame: Baseline (pre-intervention), immediately post-intervention, and 4-week follow-up
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.
Knowledge retention in obstetrics Health Nursing
Time frame: Baseline (pre-intervention), immediately post-intervention, and 4-week follow-up
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Eman Atef Elsokary, PhD principal investigator
Faculty of Nursing, Helwan University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-Based Learning (PBL) and Traditional Lecture-Based Instruction in people with Problem-based Learning in Nursing Education, run by Eman Atef Elsokary 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?
The sponsor lists 6 inclusion and 0 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: finished, as of the sponsor's last update on 28 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Critical Thinking Skills (time frame: Baseline (pre-intervention), immediately post-intervention, and 4-week follow-up). The study lists 3 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 28 Jan 2026.