- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07464652
Objectıve Structured Clınıcal Examınatıon Stress For Intravenous Perıpheral Catheterızatıon
Investıgatıon Of The Effect Of Intravenous Peripheral Catheterızatıon Objectıve Structured Clınıcal Examınatıon Applıcatıon On The Stress And Skıll Levels Of Nursıng Students
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ece Kurt
- Phone Number: 90 462 377 8880
- Email: ece_ece3543@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 24.11.2025/ 743406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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