- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07670364
Standardized Patients in Arterial Pressure Monitoring Training
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.
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.
연구 개요
상태
상세 설명
- 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.
7. 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).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Zeynep GÜRKAN, PhD
- 전화번호: +905389786500
- 이메일: zeynepgurkan@yyu.edu.tr
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Standardized Patient Group
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.
|
This behavioural intervention consists of an advanced simulation session following standard theoretical and practical training.
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활성 비교기: Static Manikin Group
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.
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This behavioural intervention consists of an advanced simulation session following standard theoretical and practical training.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cognitive Load Level
기간: Within the same day, immediately after the completion of the simulation procedure (Day 1)
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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.
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Within the same day, immediately after the completion of the simulation procedure (Day 1)
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Clinical Self-Efficacy Level
기간: Within the same day, immediately after the completion of the simulation procedure (Day 1).
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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.
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Within the same day, immediately after the completion of the simulation procedure (Day 1).
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- Bronicki RA. Hemodynamic Monitoring. Pediatr Crit Care Med. 2016 Aug;17(8 Suppl 1):S207-14. doi: 10.1097/PCC.0000000000000779.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .