NCT07670364

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Oct 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 16, 2026

Last Update Submit

June 24, 2026

Conditions

Keywords

Standardized PatientArterial Pressure MonitoringCognitive LoadClinical SkillsSelf-EfficacyNursing EducationSimulation-Based Training

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Study Arms (2)

Standardized Patient Group

EXPERIMENTAL

Participants 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.

Behavioral: Arterial Pressure Monitoring Training

Static Manikin Group

ACTIVE COMPARATOR

Participants 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.

Behavioral: Arterial Pressure Monitoring Training

Interventions

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

Standardized Patient GroupStatic Manikin Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 34263238BACKGROUND
  • 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.

    PMID: 24168451BACKGROUND
  • 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.

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

    PMID: 27490601BACKGROUND

Central Study Contacts

ZEYNEP GÜRKAN, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 26, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share