The Urinary Catheterization Training on Skills, Satisfaction and Self-Confidence in Nursing Students

January 24, 2023 updated by: ECE KURT, Cukurova University

The Effects of Virtual Reality Simulation, Computer Based Simulation and Low Reality Simulation Methods Used in Urinary Catheterization Training on Skills, Satisfaction and Self-Confidence in Nursing Students

In our study, it is planned to use three different simulation methods. One of these; It is a low-reality simulator, a hip model. It is known that this model is used by many universities in nursing education today and is called the traditional method. Both of the other simulators the investigators will use are high-fidelity models. One of them is a computer-based full-body manikin and the other is a virtual reality simulation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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

The research was designed as a randomized controlled experimental study to determine the effects of virtual reality simulation, computer-based simulation and low-reality simulation methods used in urinary catheterization training on skills, satisfaction and self-confidence in nursing students. The research will be carried out in Çukurova University Health Sciences Faculty Nursing Department Vocational Skills Laboratory in the spring semester of 2022-2023 academic year. The students who will participate in the research do not have clinical practice experience yet.

The computer-based simulation model (S550.100 Noelle, Gynecology Model) to be used in our study consists of the full human body and can produce real human sounds (pain response, fear, etc.). Thus, thanks to the computer connection, the communication between the student and the simulator is increased and the reality of the clinical environment is maintained. Person performing urinary catheterization on the simulator; can feel the resistance of structures such as urethra, sphincter and bladder, which are similar to the anatomical structure of the real patient. When the catheter enters the bladder, as in a real patient, artificial urine (yellow water) flows through the catheter and the catheter balloon can be fully inflated/deflated during catheter insertion/removal.

Considering the technical features of the virtual reality simulator, which is another simulator to be used in our study; Thanks to the glasses used, it is possible to say that the patient and hospital environment are presented to the students in 3D with high reality. With the use of glasses, students will be able to perform urinary catheterization with the joysticks they hold in their hands. Thanks to this technology, it is possible for students to evaluate themselves by facing situations that are difficult to control in real life, as if they are actually experiencing them, to gain the right knowledge and skills through the mistakes they have made, and to gain experience by developing their sense of confidence.

Another simulator to be used in the study is a low-reality hip model. This is a model used to gain the ability to apply urinary catheterization and only female external reproductive organs can be seen. While the catheter moves through the urinary system and enters the bladder, the feeling of resistance and pressure experienced on real patients cannot be experienced. After the catheter is integrated into the external reproductive organ, operations such as seeing its progress along the urethra and bladder, controlling its location and inflating the balloon cannot be performed. It is the traditional method used for urinary catheterization practice training of nursing students.

The sample size was calculated by Power analysis (G*Power 3.1.9.2) based on a similar study done before. Based on the results of students' self-confidence and satisfaction levels, a total of 156 samples were determined for each group with a test power of 0.80, 95% confidence (1-α) and an effect size of f=0.25, with a minimum of 53 samples. identified as a student. In the 2022-2023 academic year, the Department of Nursing enrolled 182 students in the first class. All students who meet the criteria to participate in the research will be assigned to one of the three simulation groups using simple random sampling method. Students will be listed taking into account the last three digits of the school number. The web address https://www.randomizer.org will be used for random assignment.

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 (Anticipated)

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.
156

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

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

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To register for the Nursing Fundamentals II Course for the first time,
  • Volunteering to participate in the research,

Exclusion criteria from the study:

  • To be a graduate of Health Vocational High School,
  • Working as a nurse/midwife
  • Have any previous experience of urinary catheterization,

Exclusion Criteria:

  • Not attending the theoretical lesson,
  • Not participating in demonstration and group work,
  • Not participating in skill measurements

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: Double

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: low-reality simulation Group
In this group, urinary catheterization will be performed through a plastic half-hip model.
Other: Use of simulation in urinary catheterization training
To train students on urinary catheterization by using one of 3 different simulation methods.
Experimental: Computer Based Simulation Group
In this group, urinary catheterization will be performed through a computer-based full-body model.
Other: Use of simulation in urinary catheterization training
To train students on urinary catheterization by using one of 3 different simulation methods.
Experimental: Virtual Reality Simulation Group
In this group, urinary catheterization will be performed through a software based on virtual reality technology.
Other: Use of simulation in urinary catheterization training
To train students on urinary catheterization by using one of 3 different simulation methods.

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
Urinary Catheterization Practice Skills Evaluation
Time Frame: 10 minutes
-Each student's urinary catheterization practice will be video-recorded one by one by the researcher, and then the videos will be watched and the "Urinary Catheterization Skills Checklist" will be filled.
10 minutes

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
Student Satisfaction and Self Confidence Measurement
Time Frame: 10 minutes
- At the end of the application, students will fill in the "Student Satisfaction and Self Confidence in Learning Scale".
10 minutes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Simulation Design Evaluation
Time Frame: 10 minutes
At the end of the application, students will fill in the "Simulation Design Scale".
10 minutes

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.
Cukurova University

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.
Tübitak

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 (Anticipated)

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.
February 14, 2023

Primary Completion (Anticipated)

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.
February 28, 2023

Study Completion (Anticipated)

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.
April 4, 2023

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).
January 14, 2023

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.
January 24, 2023

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.
February 2, 2023

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.
February 2, 2023

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.
January 24, 2023

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.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • Cukurova Ece Kurt SBF 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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