OSCE (Objective Structured Clinical Examination)NCT07464652
Objectıve Structured Clınıcal Examınatıon Stress For Intravenous Perıpheral Catheterızatıon
A study testing OSCE in people with OSCE (Objective Structured Clinical Examination) and Stress, run by Cukurova University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- OSCE (Objective Structured Clinical Examination), Stress, Nursing Education
- What is being tested?
- OSCE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- OSCE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: OSCE |
| routine practice | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start20 May 2026 (estimated)
- Primary completion23 May 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSCE (Objective Structured Clinical Examination)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ECE KURT, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464652
- Sponsor's protocol ID
- 24.11.2025/ 743406
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Students will not be asked for permission to share their data.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investıgatıon Of The Effect Of Intravenous Peripheral Catheterızatıon Objectıve Structured Clınıcal Examınatıon Applıcatıon On The Stress And Skıll Levels Of Nursıng Students
- ClinicalTrials.gov ID
- NCT07464652
- Acronym / sponsor ID
- 24.11.2025/ 743406
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 23 May 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| objective exam | Experimental | Other: OSCEIn 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. |
| routine practice | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSCEStudents 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 | Other | objective exam |
Primary outcome
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No. Students will not be asked for permission to share their data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing OSCE in people with OSCE (Objective Structured Clinical Examination) and Stress, run by Cukurova University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ece Kurt (90 462 377 8880, ece_ece3543@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS stress level (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.