Objectıve Structured Clınıcal Examınatıon Stress For Intravenous Perıpheral Catheterızatıon

March 6, 2026 updated by: ECE KURT, Cukurova University

Investıgatıon Of The Effect Of Intravenous Peripheral Catheterızatıon Objectıve Structured Clınıcal Examınatıon Applıcatıon On The Stress And Skıll Levels Of Nursıng Students

In this planned study, the stress levels of nursing students regarding intravenous access during the OSCE (Objective Structured Clinical Examination) will be measured using self-report questionnaires and smartwatches. Stress levels will be compared with those of another student group who did not undergo the OSCE assessment but performed intravenous access procedures.

Study Overview

Status

Status

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

Conditions

Conditions

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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.

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.
52

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.

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:

  • The students are enrolled in the Fundamentals of Nursing II course for the first time, will be experiencing OSCE for the first time, and have volunteered to participate in the research.

Exclusion Criteria:

  • The reasons for the students' disqualification include their graduation from a vocational health high school or their studies in a health-related field, their lack of prior experience in basic nursing skills, their failure to participate in laboratory work conducted as part of the course, and their incomplete completion of tests.

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: objective exam
In this group, students' stress levels before entering the first station in the OSCE will be determined using the State Anxiety Inventory and a smartwatch. Immediately afterward, while the student is performing IV catheter insertion at the station, the procedure steps will be evaluated by the instructor using a Skill Checklist. At the end of the procedure, students' stress levels will be re-evaluated using the State Anxiety Inventory and a smartwatch.
Other: OSCE
Students will be assigned to experimental and control groups based on their knowledge test scores using block randomization. The following day, all students will be taken to the laboratory for practice. The instructor will demonstrate IV catheter insertion once on a mannequin, following the procedural steps, and then students will work with the instructor in groups of eight. Each student will practice the procedure on the mannequin at least once. Students in the experimental group will undergo OSCE (Obstructive Skills Test). The OSCE will be prepared in a laboratory setting with two stations where students will practice their skills. Students will be asked to perform IV catheter insertion at the first station. At the second station, students will perform a procedure chosen by lottery. Students will not be evaluated on the skill at the second station. Students will have 5 minutes to perform the skill at each station. A bell will ring every 5 minutes, and students will move from one stat
No Intervention: routine practice

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
VAS stress level
Time Frame: 1 day

At the beginning and end of the program, students' stress levels will be reassessed using the State Anxiety Inventory.

The Visual Analog Scale for Stress (VAS): Based on the logic of subjectively marking the intensity of a specific emotional state on a one-dimensional line, it has become widely used over time in measuring variables such as pain, anxiety, and stress. The VAS form used specifically for stress was developed to determine the immediate stress level felt by participants in a practical, rapid, and highly sensitive manner. The scale is applied by placing a single mark on a 10 cm long line between the endpoints "I am not stressed at all" and "I am currently feeling very stressed." This mark is measured in millimeters from the left end and converted into a numerical score between 0 and 10; this structure minimizes the workload for participants while providing researchers with high-resolution, continuous data.
1 day
Intravenous Catheter Insertion Skill Evaluation
Time Frame: 1 day

During the activity, the skills of students in both groups will be assessed using a checklist.

Intravenous Catheter Insertion Skill Checklist: Prepared by researchers in accordance with the literature. The final version was then finalized after obtaining the opinions of 10 academics specializing in the Fundamentals of Nursing. The intravenous skill checklist consists of a total of 27 procedural steps. Each step is evaluated as "correctly performed" (1 point) or "incorrectly performed" (0 points).
1 day
Stress level measurement using a smartwatch
Time Frame: 1 day
At the beginning and end of the practice, physiological stress levels will be measured using a smartwatch. For smart measurement, a Huawei Watch Fit 2 device will be used, employing a wrist-based optical heart rate sensor (HUAWEI TruSeen™ 5.0) and the HUAWEI TruRelax™ algorithm based on HRV (heart rate variability). Thanks to this algorithm, the watch transmits the results of low-level stress (1-29), normal-level stress (30-59), moderate-level stress (60-79), and high-level stress (80-99) to a mobile application on the researcher's cell phone.
1 day

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

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 (Estimated)

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.
May 20, 2026

Primary Completion (Estimated)

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.
May 23, 2026

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.
December 20, 2026

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).
February 23, 2026

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.
March 6, 2026

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.
March 11, 2026

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.
March 11, 2026

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.
March 6, 2026

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.
March 1, 2026

More Information

Terms related to this study

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.
  • 24.11.2025/ 743406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Students will not be asked for permission to share their data.

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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