- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Istanbul, Tyrkia (Türkiye)
- Acıbadem Mehmet Ali Aydınlar University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Kontrollgruppe
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This is a standard theoretical and practical training session that demonstrates the step-by-step process of measuring arterial blood pressure using a simulator.
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Eksperimentell: Studie gruppe
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Level of theoretical knowledge
Tidsramme: From the baseline through the end of the 21st day
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A 10-question test was developed to assess theoretical knowledge of blood testing.
The total score is calculated out of 100.
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From the baseline through the end of the 21st day
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Psychomotor performance related to arterial blood pressure measurement
Tidsramme: Until the end of the 21st day
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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.
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Until the end of the 21st day
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Practitioner Competency Test
Tidsramme: From the baseline through the end of the 21st day
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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.
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From the baseline through the end of the 21st day
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Satisfaction and Self-Confidence Scale
Tidsramme: Until the end of the 21st day
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Until the end of the 21st day
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2025-18/690
Plan for individuelle deltakerdata (IPD)
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