NCT06359405

Brief Summary

This study aims to objectively evaluate student nurses' crisis management skills in drug safety simulation and examine an effective intervention to improve these skills through a randomized controlled study. The research aims to provide important findings that will contribute to the determination of strategies to increase the competencies of student nurses in the fields of drug safety and crisis management. Research Hypotheses: H1: The application of drug safety simulation has an effect on the crisis management skill level of nursing students. The aim of the intervention is to develop a simulation program to enhance nursing students' crisis management skills in drug safety. This simulation program will provide students with the opportunity to recognize, assess, and effectively intervene in medication errors in real-world scenarios. The simulation program will include interactive case scenarios, virtual patients, and simulation sessions led by an instructor providing feedback to students. Additionally, learning materials covering topics such as prevention, recognition, and correction of medication errors will be provided

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 2, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

April 20, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

11 days

First QC Date

April 2, 2024

Last Update Submit

April 12, 2024

Conditions

Keywords

Nursing studentsMedical ErrorsCrisis managementRandomized Controlled TrialSimulation Training

Outcome Measures

Primary Outcomes (1)

  • The effect of drug safety simulation application on the crisis management skill level of nursing students.

    The scale items are designed to make it easier for managers to answer: Before the crisis, During the crisis and Aftermath of the crisis The questionnaire was presented in three separate sections. In order to determine the crisis management approaches of nurse managers The answers given to the statements in the PBS used in the research are 5-point Likert type, The score ranged from 1 to 5 points from never to always. Accordingly; 1. Never 2. Very rare 3. Occasionally 4. Most of the time 5. Always. 50 In addition, the mean scores of the sub-dimensions of the PBS; 1.00-1.79 points range is very negative 1.80-2.59 points is negative 2.60- 3.39 points in the range of 2.60- 3.39 points, medium level 3.40-4.19 points is positive A score between 4.20-5.00 is considered very positive

    3 Months

Study Arms (2)

Working group

EXPERIMENTAL

The intervention will take place by presenting the simulation program to the working group.

Behavioral: drug safety simulation

Control group

NO INTERVENTION

The control group will receive standard nursing education but not additional intervention.

Interventions

The intervention's purpose is to develop a simulation program to increase nursing students' crisis management skills regarding medication safety. This simulation program will provide students with the opportunity to develop skills in recognizing, evaluating, and effectively intervening in medication errors in real-world scenarios. The simulation program will include interactive case scenarios, virtual patients, and simulation sessions led by an instructor providing feedback to students. Also, medicine Learning materials covering preventing, recognizing, and correcting errors will also be provided.

Working group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years old
  • Be registered in the nursing department
  • Continuing formal education
  • Having taken a Management course in Nursing

You may not qualify if:

  • Being enrolled in a different program
  • Change of department/school
  • The student has a desire to leave the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Seda Baykara Mat, Dr.

    Asst. Prof.

    STUDY DIRECTOR

Central Study Contacts

Seda Tuğba Baykara Mat, Dr.

CONTACT

Cisem Bastarcan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The researchers declare that the data obtained from randomly formed groups will be numbered and entered into the statistical analysis program to hide the identity information and that two researchers will be assigned during the entry.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study was planned as a randomized controlled study to evaluate the crisis management skills of student nurses in drug safety simulation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 11, 2024

Study Start

April 20, 2024

Primary Completion

May 1, 2024

Study Completion

May 2, 2024

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

The information obtained from this study will be used entirely for research purposes and personal information will be kept confidential.