NCT06971679

Brief Summary

Nurses need to develop critical thinking skills to be competent in flexible, personalized, and situation-specific problem solving in today's healthcare environment of rapid change and increasing information. This means that nursing education should prepare nursing students to meet the needs of patients, serve as leaders, develop scientific rigor for the benefit of patients, and make decisions based on critical thinking. In addition to transferring theoretical knowledge, nursing education is also very important in terms of putting students' knowledge into practice and improving students' comprehensive qualifications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

April 20, 2025

Last Update Submit

May 6, 2025

Conditions

Keywords

Problem-based learningNursing studentsFlipped Classroom MethodsPatient Safety

Outcome Measures

Primary Outcomes (5)

  • Socio-demographic Characteristics Form

    The socio-demographic characteristics form prepared by the researchers consisted of four questions: age, gender, the status of receiving training on medical errors and patient safety outside the curriculum, and the source of the training.

    Baseline

  • H-PEPSS TR

    The H-PEPSS TR is a 23-item, two-level measurement tool. It consists of two main dimensions: "Classroom" and "Clinical environment". The scale consists of six sub-dimensions. Item total score averages are used in the whole scale and sub-dimensions. Each item of the scale is evaluated as "Strongly disagree-1 point" and "Strongly agree-5 points" on a five-point. The higher the score obtained from the "classroom" dimension and sub-dimensions of the scale, the higher the participants' perceptions of patient safety knowledge developed in the classroom environment.The higher the score obtained from the "clinical environment" dimension and sub-dimensions of the scale, the higher the participants' perceptions of patient safety competence developed in the clinical environment.

    Baseline and 4 weeks after the intervention

  • Patient Safety Competency Self-Assessment Tool

    Item total score averages are used in the total scale and sub-dimensions. The minimum score that can be obtained from the scale and sub-dimensions is 1 and the maximum score is 5. Higher mean scores indicate that students have better knowledge, skills and attitudinal competencies in patient safety. Since the instrument is a multidimensional scale, the mean scores of the total scale, 3 dimensions and 12 factors are evaluated separately. Each item of the scale is evaluated in a five-point Likert scale with different expressions in each dimension; The knowledge dimension consists of 2 factors and 6 items in total. Its evaluation is as "1=I have no knowledge at all, 5=I know very well". The skills dimension consists of a total of 6 factors and 21 items. Its evaluation is as "1=I cannot do it at all, 5=I can do it very easily". Attitude dimension consists of 4 factors and 14 items. The evaluation is "1=Strongly disagree, 5=Strongly agree".

    Baseline and 4 weeks after the intervention

  • Case Test and Open-Ended Question

    A 20-question patient safety events test and two open-ended case questions (cause of error, risks, influencing factors, developing strategies for prevention, incident reporting and root causes) were created by the researchers and administered as a test. The test was evaluated out of 100 points. This is an evalution test exam, the minimum point is 65 for success.

    4 weeks after the intervention

  • PBL Modules

    Modules were prepared by the researchers. The cases and questions in the case test were structured as PBL cases to compare the module content assessments. In PBL modules, students were asked to conduct root cause analysis on reported medical error scenarios. In this analysis, module work including the cause of the error, risks, influencing factors, suggestions for prevention, extraction of the root causes of the event, etc. was carried out. In the evaluation of each group, points were given according to the 100-point system. Case test results were evaluated as correct answers. PBL cases were scored on the realization of the implementation steps. This is an evaluation exam and 65 point for be success.

    4 weeks after the intervention

Study Arms (2)

Didactic Group

NO INTERVENTION

In the first week of the clinical practice, the control group students were given patient safety training by the researcher using the classical didactic method on the same day and time as the intervention group students. After the training, a case test was applied to the students.

Flipped Group

EXPERIMENTAL

In the first week of the clinical practice, the E-learning module prepared by the researchers within the scope of the flipped education method was shared with the intervention group students and all students were shown in a conference room. After the training, PBL modules (different cases related to patient safety for each group) were shared with the students divided into groups of 3-5 students within the scope of PBL and they were given one week to prepare. In the other weeks of the clinical practice, face-to-face case discussions were held with the groups. These case discussions lasted an average of 40 minutes.

Behavioral: Flipped Method

Interventions

Flipped MethodBEHAVIORAL

In the first week of the clinical practice, the E-learning module prepared by the researchers within the scope of the flipped education method was shared with the intervention group students and all students were shown in a conference room. After the training, PBL modules (different cases related to patient safety for each group) were shared with the students divided into groups of 3-5 students within the scope of PBL and they were given one week to prepare. In the other weeks of the clinical practice, face-to-face case discussions were held with the groups. These case discussions lasted an average of 40 minutes.

Flipped Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Academic Year Fall Semester enrolled in the Nursing Management Lesson,
  • agreed to participate in the study
  • completed the data collection forms completely

You may not qualify if:

  • want to leave the research at any time of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University Kumluca Faculty of Health Science

Antalya, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 20, 2025

First Posted

May 14, 2025

Study Start

October 7, 2024

Primary Completion

January 20, 2025

Study Completion

January 20, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Locations