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Arterial PressureNCT07670364

Standardized Patients in Arterial Pressure Monitoring Training

A study testing Arterial Pressure Monitoring Training in people with Arterial Pressure and Blood Pressure Determination, run by Yuzuncu Yil University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate and compare the effects of using standardized patients versus static manikins in nursing education for arterial blood pressure monitoring and stabilization training. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
What is being tested?
Arterial Pressure Monitoring Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
No sites listed yet
Study dates
15 Oct 2026to 30 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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Being a undergraduate nursing student currently enrolled in the specified nursing department/faculty.
  • Volunteering to participate in the study and providing written informed consent.
  • Taking the relevant clinical nursing course for the first time.
  • Having successfully completed the baseline theoretical lectures related to vital signs and basic invasive procedures.

Who cannot join

  • Having prior formal clinical experience or advanced training regarding invasive arterial blood pressure monitoring or line stabilization.
  • Having a known physical or visual impairment that would prevent the participant from performing psychomotor simulation tasks.
  • Repeating the academic year or the clinical course due to prior failure. --Withdrawing from the study voluntarily or failing to attend the mandatory 45-minute baseline theoretical training session.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

ZEYNEP GÜRKAN, PhD contact

+905389786500

zeynepgurkan@yyu.edu.tr

About this study

Official title: The Effect of Using Standardized Patients in Arterial Blood Pressure Monitoring Training on Cognitive Load, Clinical Skills, and Self-Efficacy: A Randomized Controlled Trial

This study aims to evaluate and compare the effects of using standardized patients versus static manikins in nursing education for arterial blood pressure monitoring and stabilization training. The primary objective is to investigate the impact of these two different simulation methods on students' cognitive load, clinical skills, and self-efficacy levels.

Arterial pressure monitoring is a critical, invasive intervention commonly performed in intensive care units and operating rooms, requiring a high degree of precision. While traditional technical skill assessments usually focus solely on procedural success scores or completion speed, this study utilizes the framework of Cognitive Load Theory to examine the mental toll (intrinsic, extrinsic, and germane load) and psychological readiness (self-efficacy) experienced by nursing students during the procedure.

Read more

The study will be conducted as a randomized controlled experimental trial with 3rd-year nursing students who have successfully completed their Medical-Surgical Nursing course. Participants will be randomly assigned to either the experimental group or the control group:

The Experimental Group will receive theoretical and practical training, followed by performing the arterial pressure monitoring line stabilization on a "Standardized Patient" (an experienced healthcare professional acting a scenario with a moving limb to mimic real clinical chaos without any actual invasive intervention).

The Control Group will receive the same training but will perform the stabilization procedure on a traditional static medical manikin.

Data will be collected using a Descriptive Information and Performance Recording Form (to measure procedural time and error rates), the Cognitive Load Scale, and the Self-Efficacy Scale for Clinical Skills. Measurements will be taken at baseline (pre-test) and immediately after the intervention (post-test). The findings of this study are expected to provide evidence-based guidance for developing "mind-friendly" nursing curricula and safer, more realistic simulation protocols that enhance student self-efficacy while ensuring patient safety before entering actual clinical environments.

Read the detailed description
  1. Study Design and Setting This study is designed as a randomized controlled, parallel-group experimental trial. The study will be conducted at the Nursing Principles Application Laboratory of the Faculty of Health Sciences at Van Yüzüncü Yıl University (YYÜ). Data collection will begin following approval from the Institutional Review Board (Ethics Committee) and necessary institutional permissions, and the study is projected to be completed within one year.
  2. Participants and Sample SizeThe study population consists of 3rd-year nursing students enrolled at the Faculty of Health Sciences at Van Yüzüncü Yıl University (YYÜ). Eligible participants must have successfully completed the "Medical-Surgical Nursing" course and possess prior clinical application experience.The required sample size was determined through an a priori power analysis using G*Power software (version 3.1.9.4), based on an independent samples t-test to detect differences between two independent groups. The a priori analysis indicated that a minimum sample size of 37 participants per group-resulting in a total of 74 participants-is required to fulfill the targeted 95% statistical power for this study.
  3. Randomization and Interventions Eligible participants will be randomly assigned to either the Experimental Group or the Control Group. Both groups will initially receive identical theoretical and practical training regarding invasive arterial blood pressure monitoring and line stabilization. Experimental Group (Standardized Patient Simulation): Following the training, participants in this group will perform the arterial pressure monitoring line stabilization on a Standardized Patient (SP). Control Group (Static Manikin Simulation): Following the training, participants in this group will perform the exact same stabilization procedure on a traditional, static medical manikin.
  4. Standardized Patient (SP) and Scenario Details To ensure high realism and standardization, an experienced nurse with at least 5 years of clinical experience in a Cardiovascular Surgery (CVS) intensive care unit will portray the SP. Safety: No actual invasive arterial cannulation will be performed on the SP. Instead, a realistic simulation setup will be established by placing a pre-fixed cannula appearance on the SP's radial region. Scenario: The scenario is designed based on a "restless/moving patient" parameter to test cognitive load and clinical adaptation. The SP will move their limb at pre-determined intervals and with standard intensity for every participant, introducing a standardized physical challenge. The SP will not engage in verbal interaction to isolate the "mechanical skill" variable.
  5. Data Collection ToolsData will be gathered chronologically using three primary instruments:Descriptive Information and Performance Recording Form: Developed by the researchers, the first part captures sociodemographic data, academic GPA, prior simulation experience, and baseline readiness. The second part is filled out simultaneously by the researcher to objectively record the total procedural time, error rates, and technical success scores.
  • Cognitive Load Scale (Different Cognitive Load Types Scale)
  • Self-Efficacy Scale for Clinical Skills Data Collection ProcedurePre-test Phase: All participants will be informed about the study, sign the Informed Consent Form, and complete the Descriptive Information Form, Cognitive Load Scale, and Self-Efficacy Scale to establish baseline data.

Training Phase: Standardized education on arterial pressure monitoring will be delivered to both groups.

Implementation Phase: The Experimental group will complete the procedure on the SP, while the Control group completes it on the manikin. Researchers will record procedural time and errors using the Performance Form.

Post-test Phase: Immediately after completing the procedure, participants in both groups will re-fill the Cognitive Load Scale and Self-Efficacy Scale.

  1. Statistical AnalysisData will be analyzed using SPSS version 25.0. Descriptive statistics (percentages, means, standard deviations) will summarize the data. Categorical variables will be compared using Pearson's Chi-Square and Fisher's Exact tests. Continuous variables between groups will be evaluated using Independent Samples t-test and One-Way ANOVA. Relationships between scales will be analyzed using Pearson correlation (normal distribution) or Spearman correlation (non-normal distribution). The significance level will be set at a 95% confidence interval (p < 0.05).
Being tested
Arterial Pressure Monitoring Training
Keywords
Standardized Patient, Arterial Pressure Monitoring, Cognitive Load, Clinical Skills, Self-Efficacy, Nursing Education, Simulation-Based Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arterial Pressure Monitoring TrainingBehavioural

    This behavioural intervention consists of an advanced simulation session following standard theoretical and practical training.

Study groups in NCT07670364
Study groupRoleWhat they receive
Standardized Patient GroupExperimentalParticipants in this group will receive standard theoretical and practical training on invasive arterial blood pressure monitoring and line stabilization. Following the training, students will perform the arterial pressure monitoring line stabilization procedure on a Standardized Patient (SP). The SP will be depicted by an experienced cardiovascular surgery nurse who will simulate a restless clinical scenario by moving their limb at predetermined intervals and with a standard intensity. No actual invasive cannulation will be performed; instead, a pre-fixed cannula appearance will be established on the SP's radial region. Cognitive load and clinical self-efficacy scales will be administered as pre-tests before the training and as post-tests immediately after the simulation procedure. Procedural time and technical errors will also be recorded.
Receives: Behavioral: Arterial Pressure Monitoring Training
Static Manikin GroupActive comparatorParticipants in this group will receive the exact same standard theoretical and practical training on invasive arterial blood pressure monitoring and line stabilization. Following the training, students will perform the identical line stabilization procedure on a traditional, static medical manikin in the nursing laboratory setup. Unlike the experimental group, the manikin will remain completely stationary, representing the traditional simulation approach. Cognitive load and clinical self-efficacy scales will be administered as pre-tests before the training and as post-tests immediately after the manikin procedure. Procedural time and technical errors will be recorded simultaneously by the researchers.
Receives: Behavioral: Arterial Pressure Monitoring Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive Load Level

    Assessed using a standardized Cognitive Load Scale (or Cognitive Load Questionnaire). This scale measures the mental effort and cognitive burden experienced by students during the arterial pressure monitoring stabilization procedure. The total score ranges from a minimum score to a maximum score [10 to 100]. Higher scores indicate a higher level of cognitive load and mental fatigue during the clinical task.

    Measured: Within the same day, immediately after the completion of the simulation procedure (Day 1)

  2. Clinical Self-Efficacy Level

    Assessed using a standardized Clinical Self-Efficacy Scale to measure nursing students' self-confidence and perceived competence regarding invasive arterial blood pressure monitoring and line stabilization. The total score ranges from a minimum score to a maximum score [5 to 25]. Higher scores indicate greater self-efficacy and clinical confidence.

    Measured: Within the same day, immediately after the completion of the simulation procedure (Day 1).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion15 Nov 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07670364
Sponsor's protocol ID
2026/04-30
Status last verified
Jun 2026
First submitted
16 Jun 2026
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Babadag K, Zaybak A. Comparing Intra-Arterial, Auscultatory, and Oscillometric Measurement Methods for Arterial Blood Pressure. Florence Nightingale J Nurs. 2021 May 11;29(2):194-202. doi: 10.5152/FNJN.2021.19103. eCollection 2021 Jun.

    PubMed 34263238
  • Tsang R. Hemodynamic monitoring in the cardiac intensive care unit. Congenit Heart Dis. 2013 Nov-Dec;8(6):568-75. doi: 10.1111/chd.12148. Epub 2013 Oct 30.

    PubMed 24168451
  • Tucker D, Hazinski MF. The nursing perspective on monitoring hemodynamics and oxygen transport. Pediatr Crit Care Med. 2011 Jul;12(4 Suppl):S72-5. doi: 10.1097/PCC.0b013e3182211d5b.

    PubMed 22129554
  • Bronicki RA. Hemodynamic Monitoring. Pediatr Crit Care Med. 2016 Aug;17(8 Suppl 1):S207-14. doi: 10.1097/PCC.0000000000000779.

    PubMed 27490601

Questions about this trial

What is this clinical trial studying?

A study testing Arterial Pressure Monitoring Training in people with Arterial Pressure and Blood Pressure Determination, run by Yuzuncu Yil 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 4 inclusion and 3 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 26 Jun 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 ZEYNEP GÜRKAN, PhD (+905389786500, zeynepgurkan@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Load Level (time frame: Within the same day, immediately after the completion of the simulation procedure (Day 1)). 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?

On the ClinicalTrials.gov record for NCT07670364, which also lists 4 linked publications.

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 26 Jun 2026.

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