NCT07464652

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
May 2026Dec 2026

First Submitted

Initial submission to the registry

February 23, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 20, 2026

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Expected
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3 days

First QC Date

February 23, 2026

Last Update Submit

March 6, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • VAS stress level

    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

    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

    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

Study Arms (2)

objective exam

EXPERIMENTAL

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

routine practice

NO INTERVENTION

Interventions

OSCEOTHER

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

objective exam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 11, 2026

Study Start

May 20, 2026

Primary Completion

May 23, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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