NCT07736755

Brief Summary

Patient safety education is important for preparing nursing and midwifery students to recognize risks, prevent avoidable harm, and provide safe care. This study evaluated whether adding structured online learning activities to face-to-face patient safety education improved students' perceived patient safety competence and general self-efficacy. First-year nursing and midwifery students were assigned to either a blended learning group or a face-to-face education group. Both groups received the same patient safety content through four classroom sessions delivered over two weeks. The blended learning group also used online case scenarios, scientific articles, topic summaries, and other educational resources. Outcomes were assessed before the educational program, immediately after the program, and two weeks later. This completed educational intervention study was registered retrospectively following a journal editorial request.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2026

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

May 15, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

28 days

First QC Date

July 27, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

Blended LearningPatient Safety CompetenceSelf-EfficacyNursing StudentsMidwifery StudentsHealth Professions Education

Outcome Measures

Primary Outcomes (1)

  • Patient Safety Competency Self-Evaluation Tool Total Mean Score

    Perceived patient safety competence was assessed using the Turkish version of the 41-item Patient Safety Competency Self-Evaluation Tool. Items are rated on a 5-point Likert scale, and items 38 and 39 are reverse scored. The total score is calculated as the mean of all item scores and ranges from 1 to 5, with higher scores indicating greater perceived patient safety competence.

    Baseline, immediately after the two-week intervention, and two weeks after completion of the intervention

Secondary Outcomes (4)

  • Patient Safety Competency Knowledge Domain Mean Score

    Baseline, immediately after the two-week intervention, and two weeks after completion of the intervention

  • Patient Safety Competency Skills Domain Mean Score

    Baseline, immediately after the two-week intervention, and two weeks after completion of the intervention

  • Patient Safety Competency Attitudes Domain Mean Score

    Baseline, immediately after the two-week intervention, and two weeks after completion of the intervention

  • General Self-Efficacy Scale Total Score

    Baseline, immediately after the two-week intervention, and two weeks after completion of the intervention

Study Arms (2)

Blended Learning Group

EXPERIMENTAL

Participants received a two-week patient safety education program consisting of four 90-minute face-to-face classroom sessions and structured asynchronous online learning activities. The online component included patient safety case scenarios, selected scientific articles, researcher-prepared topic summaries, and supplementary educational resources. Online materials were integrated into classroom discussions and reinforced through instructor feedback.

Behavioral: Blended Patient Safety Education

Face-to-Face Education Group

ACTIVE COMPARATOR

Participants received the same two-week patient safety education content through four 90-minute face-to-face classroom sessions but did not have access to the online learning platform during the study. The educational topics, instructor, intervention period, and total face-to-face teaching time were the same as those provided to the blended learning group.

Behavioral: Face-to-Face Patient Safety Education

Interventions

A two-week educational intervention comprising four 90-minute face-to-face classroom sessions combined with asynchronous online learning activities. The online component included two patient safety case scenarios, selected scientific articles, researcher-prepared topic summaries, and supplementary educational resources. The program addressed patient identification, medication safety, communication errors, infection prevention, fall prevention, adverse event reporting, and safety culture.

Blended Learning Group

A two-week educational intervention comprising four 90-minute face-to-face classroom sessions. The program covered patient identification, medication safety, communication errors, infection prevention, fall prevention, adverse event reporting, and safety culture. Participants did not have access to the online learning platform during the study.

Face-to-Face Education Group

Eligibility Criteria

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

You may qualify if:

  • Enrollment as a first-year nursing or midwifery student at the participating university during the 2025-2026 academic year
  • No previous formal patient safety education
  • Access to a computer, tablet, or smartphone with internet access
  • Voluntary agreement to participate and provision of informed consent
  • Completion of the baseline assessment

You may not qualify if:

  • Previous formal patient safety education
  • Lack of access to a computer, tablet, or smartphone with internet access
  • Declining to participate or provide informed consent
  • Failure to complete the baseline assessment
  • Withdrawal before group allocation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences, Burdur Mehmet Akif Ersoy University

Burdur, Burdur, 15030, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Participants and the instructor were not masked because of the nature of the educational intervention. Baseline assessments were completed before participants were informed of their group allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were assigned in parallel to either a blended learning intervention group or a face-to-face education control group. Allocation was based on pre-existing student identification numbers within academic achievement strata after a lottery determined whether odd- or even-numbered identification numbers would correspond to the intervention group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start

May 15, 2026

Primary Completion

June 12, 2026

Study Completion

June 12, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the published article may be shared upon reasonable request to the corresponding author. Data will be provided subject to scientific review of the request and applicable ethical, institutional, and data protection requirements.

Time Frame
Data will be available beginning after publication of the study results and for five years following publication.
Access Criteria
Researchers with a scientifically sound proposal may request access by contacting the corresponding author. Requests will be evaluated based on the purpose of the proposed use and compliance with ethical, confidentiality, and institutional requirements.

Locations