- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07606924
The Effects of Simulation-Based Arterial Blood Pressure Training on Physical Therapy and Rehabilitation Students
The Effect of Simulation-based Arterial Blood Pressure Training on Theoretical Knowledge and Psychomotor Skills Among Physiotherapy and Rehabilitation Students: a Randomized Controlled Study
The aim of this clinical study is to assess the effectiveness of simulation-based arterial blood pressure training provided to undergraduate students in physical therapy and rehabilitation.
The main questions it aims to address are as follows:
- Does simulation-based arterial blood pressure training affect the knowledge, skills, clinical competence, satisfaction, and self-confidence of undergraduate physical therapy and rehabilitation students? To examine the effects of simulation-based arterial blood pressure training-in which students engage in hands-on practice-on theoretical knowledge, psychomotor skills, practitioner competence, satisfaction, and self-confidence, one control group will participate in the study.
Participants will:
- All participants will receive standard theoretical training on blood pressure measurement and observe a practical demonstration.
- The intervention group will additionally perform blood pressure measurements on a simulator under the supervision of an instructor.
- Assessments will be conducted at the beginning of the study and 21 days later.
Study Overview
Status
Conditions
Detailed Description
Participants will be assigned to the intervention and control groups prior to the training using a simple randomization method. Randomization will be conducted by having participants draw slips of paper labeled "1" and "2." "1" will represent the intervention group, and "2" will represent the control group.
On the first day of the study, all participants will attend a standard theoretical and practical training session where the measurement of arterial blood pressure is demonstrated step-by-step on a simulator. Participants in the intervention group will perform individual practice on the simulator under the supervision of an instructor following the demonstration. Participants in the control group will only observe the demonstration and will not perform the practice.
Assessments will be conducted at two time points: before the training and 21 days after the training. All participants' arterial blood pressure measurement skills will be scored by two evaluators who are blinded to group information, using a rubric.
In accordance with ethical principles, immediately after all evaluations in the control group are completed (on day 21), members of the control group will be given the opportunity to practice individually on the simulator.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Enrollment in the Cardiac Diseases and Rehabilitation course
- Enrollment in the Physiotherapy and Rehabilitation program at Acıbadem University
- Voluntary participation in the study and provision of informed consent
Exclusion Criteria:
- Refusal to participate in the study
- Presence of any health condition affecting the upper extremity that may limit psychomotor skills
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
|
This is a standard theoretical and practical training session that demonstrates the step-by-step process of measuring arterial blood pressure using a simulator.
|
|
Experimental: Study group
|
After participating in a standard theoretical and practical training session that demonstrated the step-by-step process of measuring arterial blood pressure using a simulator, the participants practiced individually on the simulator under the instructor's supervision.
This is a standard theoretical and practical training session that demonstrates the step-by-step process of measuring arterial blood pressure using a simulator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of theoretical knowledge
Time Frame: From the baseline through the end of the 21st day
|
A 10-question test was developed to assess theoretical knowledge of blood testing.
The total score is calculated out of 100.
|
From the baseline through the end of the 21st day
|
|
Psychomotor performance related to arterial blood pressure measurement
Time Frame: Until the end of the 21st day
|
The rubric used to assess psychomotor skills was developed by the research team based on the standard arterial blood pressure measurement steps described in the literature.
The rubric includes key procedural steps such as patient positioning, cuff placement, auscultation technique, and measurement accuracy.
Rubric evaluations will be conducted by two independent raters who are unaware of the groups.
|
Until the end of the 21st day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Practitioner Competency Test
Time Frame: From the baseline through the end of the 21st day
|
It was developed to assess participants' self-efficacy perceptions regarding blood pressure measurement.
It consists of 5 items, and each item is scored between 0 (worst) and 10 (best).
The total score is the sum of all items.
|
From the baseline through the end of the 21st day
|
|
Satisfaction and Self-Confidence Scale
Time Frame: Until the end of the 21st day
|
Until the end of the 21st day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-18/690
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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