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NCT Number: NCT07670364

Standardized Patients in Arterial Pressure Monitoring Training

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.

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

  • 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.
  • 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.
  • 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.

  • 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.

  • 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.

  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Arterial Pressure Monitoring Training

Behavioral

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

Primary outcomes

  1. Cognitive Load Level

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

    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.

  2. Clinical Self-Efficacy Level

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ZEYNEP GÜRKAN, PhD

CONTACT

[email protected]

+905389786500

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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