NurseRCSNCT06359405
Evaluation of Nursing Students' Crisis Management Skills in Medication Safety Simulation
A study testing drug safety simulation in people with Nurse, run by University of Beykent.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse
- What is being tested?
- drug safety simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2024to 2 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Be registered in the nursing department
- Continuing formal education
- Having taken a Management course in Nursing
Who cannot join
- Being enrolled in a different program
- Change of department/school
- The student has a desire to leave the study
Trial locations and contacts
No sites are listed yet.
Cisem Bastarcan contact
About this study
Official title: Evaluation of Nursing Students' Crisis Management Skills in Medication Safety Simulation: A Randomized Controlled Study
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:
Read more
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
Read the detailed description
The population and sample of the study have been calculated:
Number of 3rd and 4th-grade students: 70+71=141
Randomization: All 3rd-and 4th-grade students were included in the sample, and an independent statistician randomized them. Randomization will be done using the simple random sample selection table from the random.org website.
Control Group and Study Group: The research will use a randomized controlled trial design. Participants will be randomly assigned to two groups:
Control Group: The control group will receive standard nursing education and will not receive any additional intervention on drug safety and crisis management topics.
Study Group: The study group will participate in the simulation program and will receive the intervention designed to improve drug safety and crisis management skills.
The intervention will be implemented by providing the simulation program to the study group. The control group will receive standard nursing education but not additional intervention.
Data Collection for Post-test: Following the intervention phase, final test data will be collected from the participants.
Bias Prevention: Data from randomly generated groups will be anonymized with numbers during the research process, and entry into the statistical analysis program will be conducted in this way. Two researchers will be assigned during data entry.
Structured student introduction form: It consists of 6 questions regarding age, gender, economic status, and crisis-related experiences.
Crisis Management Scale: The scale aims to determine the approaches of school administrators to crisis management. The scale consists of 6 sub-dimensions and 45 items. The Cronbach's alpha coefficient of the Crisis Management Scale for nurse administrators is 0.85. In the study conducted with nurse administrators, after examining the internal consistency of the CMS, a reliability value of α = 0.754 was found.
Data Collection: The planned stages of data collection are listed below.
Implementation of the structured student introduction form Ensuring randomization Collection of initial test data Simulation application to the experimental group, conventional teaching method to the control group Collection of final test data
Intervention Content: The intervention aims to develop a simulation program to enhance nursing students' crisis management skills in drug safety. This simulation program will allow students to recognize, assess, and effectively intervene in medication errors in real-world scenarios. The program will include interactive case scenarios, virtual patients, and simulation sessions led by an instructor who provides student feedback. Additionally, learning materials covering topics such as prevention, recognition, and correction of medication errors will be provided.
Duration of the Intervention: The simulation program will be implemented in two stages for participants. The durations set for each stage are as follows:
Pre-test: Nursing students will take a pre-test on drug safety and crisis management topics before starting the simulation program. This test will be used to determine the students' baseline levels. The completion of the pre-test is estimated to take approximately 1 hour.
Simulation Program: The simulation program will be provided to students over several weeks. During this time, students are expected to participate in simulation sessions at specific time intervals and review educational materials on drug safety.
A detailed scenario will be used in this process. Expected behaviors in this scenario form; Knowledge, Skills and Behaviors Required Before the Scenario Knowledge - Explains the importance of drug safety.
- Knows the 8 truths in drug applications.
- Explains patient and employee safety in drug applications
- Explains the term Crisis Management
- Knows crisis management techniques Skill - Apply medication safety procedures
- Takes safety precautions in drug applications
- Applies the 8 truths in drug administration
- Manage the process during and after a crisis
- Uses crisis management techniques Behavior - Believes that medication safety is a key concept in patient and employee safety
- Believes in the necessity of safety precautions in drug administration
- Reflects the 8 truths in medication practices to care.
- Applies crisis management techniques
- Cold-blooded and cooperative behaviors will take place in the crisis management process.
Script Summary Your scenario takes place in the internal medicine ward of a hospital. A 69-year-old patient was admitted to the ward with complaints of dizziness, headache and general condition disorder. The patient was admitted from the emergency room. First intervention was made. The patient's anamnesis was tried to be taken quickly (this is how the nurse expresses it when delivering the patient). The patient has a spouse with him/her. Both the patient and his/her spouse are open to communication. You see the patient in the room for the first time. You are expected to initiate communication with the patient and perform the relevant nursing interventions.
It will include Patient Demographic Data, Standardized Patient / Simulator Features, Roles in the Simulation, and Pre-Information objectives.
Script Process Timing, Simulator Activities Expected Interventions Tips will be followed by focus group discussions using the debriefing session guide (PEARLS) to assess the alignment with the expected outputs in the Simulation Process Evaluation step.
Post-test: After completing the simulation program, students will take a post-test. This test will evaluate the student's progress in drug safety and crisis management skills following the simulation program.
The cris management scale will be used in pre and post tests.
Statistical Analysis of the Data: The data obtained in the research will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0
- Conditions
- Nurse
- Being tested
- drug safety simulation
- Keywords
- Nursing students, Medical Errors, Crisis management, Randomized Controlled Trial, Simulation Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug safety simulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Working group | Experimental | The intervention will take place by presenting the simulation program to the working group. Receives: Behavioral: drug safety simulation |
| Control group | No intervention | The control group will receive standard nursing education but not additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
- Never
- Very rare
- Occasionally
- Most of the time
- 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
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start20 Apr 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion2 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NurseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was planned as a randomized controlled study to evaluate the crisis management skills of student nurses in drug safety simulation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Tugba Baykara Mat, University of Beykent
- Investigators
- Seda Baykara Mat, Dr., Study director, Asst. Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359405
- Sponsor's protocol ID
- UBeykentUni
- Acronym
- RCS
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information obtained from this study will be used entirely for research purposes and personal information will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nursing Students' Crisis Management Skills in Medication Safety Simulation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06359405
- Acronym / sponsor ID
- RCS / UBeykentUni
- Conditions
- Nurse
- Keywords
- Nursing students, Medical Errors, Crisis management, Randomized Controlled Trial, Simulation Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 2 May 2024 (estimated)
- First posted
- 11 Apr 2024 (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 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
Detailed description
The population and sample of the study have been calculated:
Number of 3rd and 4th-grade students: 70+71=141
Randomization: All 3rd-and 4th-grade students were included in the sample, and an independent statistician randomized them. Randomization will be done using the simple random sample selection table from the random.org website.
Control Group and Study Group: The research will use a randomized controlled trial design. Participants will be randomly assigned to two groups:
Control Group: The control group will receive standard nursing education and will not receive any additional intervention on drug safety and crisis management topics.
Study Group: The study group will participate in the simulation program and will receive the intervention designed to improve drug safety and crisis management skills.
The intervention will be implemented by providing the simulation program to the study group. The control group will receive standard nursing education but not additional intervention.
Data Collection for Post-test: Following the intervention phase, final test data will be collected from the participants.
Bias Prevention: Data from randomly generated groups will be anonymized with numbers during the research process, and entry into the statistical analysis program will be conducted in this way. Two researchers will be assigned during data entry.
Structured student introduction form: It consists of 6 questions regarding age, gender, economic status, and crisis-related experiences.
Crisis Management Scale: The scale aims to determine the approaches of school administrators to crisis management. The scale consists of 6 sub-dimensions and 45 items. The Cronbach's alpha coefficient of the Crisis Management Scale for nurse administrators is 0.85. In the study conducted with nurse administrators, after examining the internal consistency of the CMS, a reliability value of α = 0.754 was found.
Data Collection: The planned stages of data collection are listed below.
Implementation of the structured student introduction form Ensuring randomization Collection of initial test data Simulation application to the experimental group, conventional teaching method to the control group Collection of final test data
Intervention Content: The intervention aims to develop a simulation program to enhance nursing students' crisis management skills in drug safety. This simulation program will allow students to recognize, assess, and effectively intervene in medication errors in real-world scenarios. The program will include interactive case scenarios, virtual patients, and simulation sessions led by an instructor who provides student feedback. Additionally, learning materials covering topics such as prevention, recognition, and correction of medication errors will be provided.
Duration of the Intervention: The simulation program will be implemented in two stages for participants. The durations set for each stage are as follows:
Pre-test: Nursing students will take a pre-test on drug safety and crisis management topics before starting the simulation program. This test will be used to determine the students' baseline levels. The completion of the pre-test is estimated to take approximately 1 hour.
Simulation Program: The simulation program will be provided to students over several weeks. During this time, students are expected to participate in simulation sessions at specific time intervals and review educational materials on drug safety.
A detailed scenario will be used in this process. Expected behaviors in this scenario form; Knowledge, Skills and Behaviors Required Before the Scenario Knowledge - Explains the importance of drug safety.
- Knows the 8 truths in drug applications.
- Explains patient and employee safety in drug applications
- Explains the term Crisis Management
- Knows crisis management techniques Skill - Apply medication safety procedures
- Takes safety precautions in drug applications
- Applies the 8 truths in drug administration
- Manage the process during and after a crisis
- Uses crisis management techniques Behavior - Believes that medication safety is a key concept in patient and employee safety
- Believes in the necessity of safety precautions in drug administration
- Reflects the 8 truths in medication practices to care.
- Applies crisis management techniques
- Cold-blooded and cooperative behaviors will take place in the crisis management process.
Script Summary Your scenario takes place in the internal medicine ward of a hospital. A 69-year-old patient was admitted to the ward with complaints of dizziness, headache and general condition disorder. The patient was admitted from the emergency room. First intervention was made. The patient's anamnesis was tried to be taken quickly (this is how the nurse expresses it when delivering the patient). The patient has a spouse with him/her. Both the patient and his/her spouse are open to communication. You see the patient in the room for the first time. You are expected to initiate communication with the patient and perform the relevant nursing interventions.
It will include Patient Demographic Data, Standardized Patient / Simulator Features, Roles in the Simulation, and Pre-Information objectives.
Script Process Timing, Simulator Activities Expected Interventions Tips will be followed by focus group discussions using the debriefing session guide (PEARLS) to assess the alignment with the expected outputs in the Simulation Process Evaluation step.
Post-test: After completing the simulation program, students will take a post-test. This test will evaluate the student's progress in drug safety and crisis management skills following the simulation program.
The cris management scale will be used in pre and post tests.
Statistical Analysis of the Data: The data obtained in the research will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was planned as a randomized controlled study to evaluate the crisis management skills of student nurses in drug safety simulation.
| Arm | Type | Receives |
|---|---|---|
| Working group | Experimental | Behavioral: drug safety simulationThe intervention will take place by presenting the simulation program to the working group. |
| Control group | No intervention | –The control group will receive standard nursing education but not additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 18 years old
- Be registered in the nursing department
- Continuing formal education
- Having taken a Management course in Nursing
Key exclusion criteria (3 listed)
- Being enrolled in a different program
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 |
|---|---|---|
| drug safety simulationThe 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. | Behavioural | Working group |
Primary outcome
The effect of drug safety simulation application on the crisis management skill level of nursing students.
Time frame: 3 Months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No. The information obtained from this study will be used entirely for research purposes and personal information will be kept confidential.
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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.
Cisem Bastarcan contact
Seda Baykara Mat, Dr. study director
Asst. Prof.
Questions about this trial
What is this clinical trial studying?
A study testing drug safety simulation in people with Nurse, run by University of Beykent.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seda Tuğba Baykara Mat, Dr. (05374337365, matsedatugba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of drug safety simulation application on the crisis management skill level of nursing students. (time frame: 3 Months). 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 16 Apr 2024.