The Effect of Simulation Method on Self-Confidence and Stress Levels in Nursing Students

July 28, 2024 updated by: Seher Yurt

The Effect of Training Given by Simulation Method on the Self-confidence and Stress Levels of Nursing Students in Patient Intervention

The aim of this study was to determine the impact of training provided through simulation method on self-confidence and stress levels in nursing students during patient intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Improving nursing students' clinical skills and enhancing their professional competencies by increasing their patient intervention skills and strengthening their ability to cope with stress is crucial. High professional confidence among nursing students is fundamental to providing effective patient care, which is critical for patient safety and satisfaction. Simulation training is an effective tool used to enhance nursing students' practical experiences in clinical settings. This method provides students with the opportunity to encounter real-life scenarios in a controlled environment and intervene in these situations. Additionally, simulation training can help develop coping skills for dealing with stress, as it prepares students for situations they may encounter in real clinical settings. The aim of this study is to determine the impact of training provided through simulation method on self-confidence and stress levels in nursing students during patient intervention.

The students included in the study will be divided into experimental and control groups through full randomization. The Student Identification Form will be administered to both groups initially. The theoretical part of Shock Nursing Care (SNC) training will be provided to the control group through in-class face-to-face education. Following the theoretical training, skills training will be conducted in the nursing skills laboratory using the demonstration method. Students will be evaluated using the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale before and after the training. The study group will receive theoretical education similarly to the control group through in-class face-to-face education. Following the theoretical education, simulation training will be conducted in the Simulation Laboratory based on the SNC Scenario. Simulation training will be conducted in groups of 10, consisting of 5 students each. Each student will be provided the SNC scenario to practice. Students will be evaluated using the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale before and after the training. The mean scores of both groups on the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale will be compared both between and within groups. Pre-graduation nursing simulation education will contribute to enhancing students' patient intervention skills and stress coping abilities.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Kağıthane
      • Istanbul, Kağıthane, Turkey, 34406
        • Recruiting
        • Istanbul Kent University
        • Contact:
          • Seher YURT, P.hD
        • Contact:
          • Zahide AKSOY, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteering to participate in the research, being a senior nursing student

Exclusion Criteria:

  • Not participating in any simulation training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: simülation intervention group
The Student Diagnosis Form, Self-Confidence/Efficacy Scale in Patient Intervention and Perceived Stress Scale will be applied first to this group. Then, face-to-face theoretical training will be given. Following the theoretical training, simulation training will be given in the Simulation Laboratory in line with the Nursing Care Scenario in Cardiogenic Shock. Simulation training will be conducted in 10 groups of 5 people and will be completed in 2 days. Each student in the group will actively participate in the simulation training within the scope of their role in the scenario. Posttests will be administered to both groups 2 weeks after the simulation training.
Other: Simulation Method
Management of cardiogenic shock scenario on an advanced simulation mannequin
No Intervention: Control group
The Student Diagnosis Form, Self-Confidence/Efficacy Scale in Patient Intervention and Perceived Stress Scale will be applied first to this group. Then, face-to-face theoretical training will be given. Post-tests will be administered 2 weeks after the theoretical training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-Confidence/Efficacy Scale in Patient Intervention
Time Frame: Pre-test, post-test (2nd weeks later)
The scale developed for health professional students with scenario-based simulation-based teaching experience includes 18 items and is evaluated according to a 5-point Likert system (1 = Strongly Disagree, 2 = Disagree, 3 = Undecided, 4 = Agree, 5 = Strongly Agree). While a high score means confidence, a low score means lack of self-confidence in students. Therefore, in clinical practice, the highest possible score is 55 and the lowest score is 11.
Pre-test, post-test (2nd weeks later)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale for Nursing
Time Frame: Pre-test, post-test (2nd weeks later)
The scale consists of 29 items and measures perceived stress for nursing.
Pre-test, post-test (2nd weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seher Yurt

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul Kent University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SEHER YURT, Istanbul Kent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IstanbulKentU-HEM-SY-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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