- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Gruppo di controllo
|
This is a standard theoretical and practical training session that demonstrates the step-by-step process of measuring arterial blood pressure using a simulator.
|
|
Sperimentale: Gruppo di studio
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Level of theoretical knowledge
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Practitioner Competency Test
Lasso di tempo: 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
Lasso di tempo: Until the end of the 21st day
|
Until the end of the 21st day
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2025-18/690
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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