Medical EducationNCT07656506
The Differential Impact of High-Stakes Versus Routine OSCE Stations on Nursing Students' Stress Levels and Clinical Competency: An Experimental Study
A study testing High-Stake OSCE in people with Medical Education, run by Torbat Heydariyeh University of Medical Sciences at 1 site in Iran.
Trial summary
Abstract Background: Objective Structured Clinical Examinations (OSCEs) are vital for assessing nursing competence. However, the design of OSCE stations, particularly comparing critical (high-stakes) versus routine (low-stakes) scenarios, may differentially impact student stress and clinical performance. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Education
- What is being tested?
- High-Stake OSCE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIran
- Study dates
- 6 Jan 2024to 5 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria included nursing students in their eighth semester who had given their consent to participate in the study
Who cannot join
- Exclusion criteria were nursing students who were unwilling to participate, absence in any of the intervention sessions, and those who, for reasons such as acute stress, did not have the necessary mental or psychological readiness to perform cardiopulmonary resuscitation skills. Additionally, students taking medications that could attenuate the stress response (e.g., beta-blockers, central nervous system depressants) were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Abstract Background: Objective Structured Clinical Examinations (OSCEs) are vital for assessing nursing competence. However, the design of OSCE stations, particularly comparing critical (high-stakes) versus routine (low-stakes) scenarios, may differentially impact student stress and clinical performance. This experimental study compared these effects to inform the optimal design of assessments.
Methods: This 2024 experimental study at Torbat Heydariyeh University randomly assigned 78 final-year nursing students to two groups (n=39 each). The Intervention Group faced a critical CPR station where failure resulted in exam disqualification, while the Control Group faced a standard routine station. Both groups received identical Basic Life Support (BLS) training in accordance with the 2020 AHA guidelines. Outcomes were assessed using: (a) the PSS-10 stress scale (α=0.85); (b) a 20-item BLS knowledge test; and (c) a 17-item CPR skills checklist, with performance metrics (depth, rate, ventilation) recorded objectively by a Laerdal QCPR® manikin. Data were analyzed using independent t-tests and the Mann-Whitney test to achieve 80% power.
- Conditions
- Medical Education
- Being tested
- High-Stake OSCE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Stake OSCEOther
In this intervention, students had to pass more challenging OSCE in comparison with contol-group
| Study group | Role | What they receive |
|---|---|---|
| Control-Group | Other | There is routine and non-stakes OSCE in the control-group Receives: Other: High-Stake OSCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress of students in OSCE exam
stress of students was measured by pss-10 questionnaire Stress levels were quantified using the Persian version of PSS-10 (α=0.85), administered via OSCE.
Measured: 1 day
BLS knowledge
Basic life support knowledge To assess students' knowledge and clinical reasoning in mechanical ventilation, a researcher-developed, mixed-format questionnaire was used. The tool included 20 items such as multiple-choice questions, clinical scenarios, calculation-based items (e.g., RSBI, ventilator settings), and graphic interpretation tasks. Content areas covered ventilator modes, complications, alarm settings, ABG analysis, and weaning criteria, designed in alignment with recent guidelines including the American Heart Association (2023). Content validity was confirmed by six experts in critical care and nursing education (CVI ≥ 0.8). A pilot test with 30 final-year students demonstrated good internal consistency (Cronbach's α= 0.84). The questionnaire was administered before and after the intervention in both study groups to evaluate learning outcomes.
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 posted18 Jun 2026
- Study start6 Jan 2024
- Primary completion27 Aug 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torbat Heydariyeh University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Sardashti, Torbat Heydariyeh University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656506
- Sponsor's protocol ID
- (IR.THUMS.REC.1402.14026)
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differential Impact of High-Stakes Versus Routine OSCE Stations on Nursing Students' Stress Levels and Clinical Competency: An Experimental Study
- ClinicalTrials.gov ID
- NCT07656506
- Acronym / sponsor ID
- (IR.THUMS.REC.1402.14026)
- Conditions
- Medical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Torbat Heydariyeh University of Medical SciencesUniversity, hospital or other
- Study start
- 6 Jan 2024 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 18 Jun 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.
Abstract Background: Objective Structured Clinical Examinations (OSCEs) are vital for assessing nursing competence. However, the design of OSCE stations, particularly comparing critical (high-stakes) versus routine (low-stakes) scenarios, may differentially impact student stress and clinical performance. This experimental study compared these effects to inform the optimal design of assessments.
Methods: This 2024 experimental study at Torbat Heydariyeh University randomly assigned 78 final-year nursing students to two groups (n=39 each). The Intervention Group faced a critical CPR station where failure resulted in exam disqualification, while the Control Group faced a standard routine station. Both groups received identical Basic Life Support (BLS) training in accordance with the 2020 AHA guidelines. Outcomes were assessed using: (a) the PSS-10 stress scale (α=0.85); (b) a 20-item BLS knowledge test; and (c) a 17-item CPR skills checklist, with performance metrics (depth, rate, ventilation) recorded objectively by a Laerdal QCPR® manikin. Data were analyzed using independent t-tests and the Mann-Whitney test to achieve 80% power.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control-Group | Other | Other: High-Stake OSCEThere is routine and non-stakes OSCE in the control-group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria included nursing students in their eighth semester who had given their consent to participate in the study
Key exclusion criteria (1 listed)
- Exclusion criteria were nursing students who were unwilling to participate, absence in any of the intervention sessions, and those who, for reasons such as acute stress, did not have the necessary mental or psychological readiness to perform cardiopulmonary resuscitation skills. Additionally, students taking medications that could attenuate the stress response (e.g., beta-blockers, central nervous system depressants) were also excluded.
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 |
|---|---|---|
| High-Stake OSCEIn this intervention, students had to pass more challenging OSCE in comparison with contol-group | Other | Control-Group |
Primary outcome
Stress of students in OSCE exam
Time frame: 1 day
stress of students was measured by pss-10 questionnaire Stress levels were quantified using the Persian version of PSS-10 (α=0.85), administered via OSCE.
BLS knowledge
Time frame: 1 day
Basic life support knowledge To assess students' knowledge and clinical reasoning in mechanical ventilation, a researcher-developed, mixed-format questionnaire was used. The tool included 20 items such as multiple-choice questions, clinical scenarios, calculation-based items (e.g., RSBI, ventilator settings), and graphic interpretation tasks. Content areas covered ventilator modes, complications, alarm settings, ABG analysis, and weaning criteria, designed in alignment with recent guidelines including the American Heart Association (2023). Content validity was confirmed by six experts in critical care and nursing education (CVI ≥ 0.8). A pilot test with 30 final-year students demonstrated good internal consistency (Cronbach's α= 0.84). The questionnaire was administered before and after the intervention in both study groups to evaluate learning outcomes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Stake OSCE in people with Medical Education, run by Torbat Heydariyeh University of Medical Sciences at 1 site in Iran.
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: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress of students in OSCE exam (time frame: 1 day). The study lists 2 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 18 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.