- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Istanbul, Turkiet (Türkiye)
- Acıbadem Mehmet Ali Aydınlar University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Kontrollgrupp
|
This is a standard theoretical and practical training session that demonstrates the step-by-step process of measuring arterial blood pressure using a simulator.
|
|
Experimentell: Studiegrupp
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Level of theoretical knowledge
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Practitioner Competency Test
Tidsram: 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
Tidsram: Until the end of the 21st day
|
Until the end of the 21st day
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2025-18/690
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .