- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07559422
Ventriloscope Simulation Stethoscope Training in PT and AT Students (VENTAS)
The Effect of Ventriloscope Simulation Stethoscope Training on Auscultation Knowledge, Skill, and Confidence in Physical Therapy and Athletic Training Students: A Longitudinal Within-Subjects Study
This longitudinal, single-cohort, within-subjects study evaluates whether sequential exposure to Ventriloscope simulation stethoscope training, delivered after traditional auscultation instruction, enhances auscultation knowledge, clinical sound recognition skill, and self-reported confidence in Physical Therapy (PT) and Athletic Training (AT) students, and whether any enhancement is retained two months after training.
All participating students receive both training modalities in sequence. Knowledge, skill, and confidence are measured at five timepoints (T1-T5) across approximately five months. A qualitative component examines student perceptions of the two training modalities.
Přehled studie
Postavení
Detailní popis
Auscultation is a required clinical competency for physical therapists and athletic trainers, yet evidence-based instructional tools remain limited. Simulation stethoscopes, such as the Ventriloscope (Lecat's SimplySim, Canton, OH), pair a standard-appearing stethoscope with a wireless transmitter that delivers pre-recorded pathologic heart and lung sounds to the learner as though originating from a live patient. Prior work has shown benefit in pharmacy, paramedic, and DPT populations, but no published study has evaluated this technology in Athletic Training students, used a within-subjects longitudinal design tracking the same participants across traditional and simulation training, or included a qualitative comparison of student perceptions.
Design: Single-cohort, longitudinal, within-subjects repeated-measures study with an embedded qualitative component.
Timepoints: T1 Pre-Traditional (May 2026); T2 Post-Traditional (May 2026); T3 Pre-Ventriloscope, ~2-month retention check (July 2026); T4 Post-Ventriloscope (July 2026); T5 2-month Follow-Up (September 2026).
Interventions: (1) Traditional auscultation training session (~90 min) including didactic lecture and peer auscultation with standard stethoscopes; (2) Ventriloscope simulation training session (~90 min) including device orientation, three-step technique instruction, and rotation through eight pre-programmed PT/AT-relevant case stations.
Rationale for single-cohort design: A two-arm design would require withholding a potentially beneficial educational intervention from half of a required clinical curriculum, which presents ethical concerns in a health professions education context. All participants receive both interventions sequentially.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Edmund Ickert, PT, DPT, PhD
- Telefonní číslo: 330-941-1326
- E-mail: ecickert@ysu.edu
Studijní záloha kontaktů
- Jméno: Morgan Bagley, PhD, AT, ATC
- Telefonní číslo: 330-941-3650
- E-mail: mcbagley@ysu.edu
Studijní místa
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Ohio
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Youngstown, Ohio, Spojené státy, 44555
- Youngstown State University
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Kontakt:
- Edmund Ickert, PT, DPT, PhD
- Telefonní číslo: 330-941-1326
- E-mail: ecickert@ysu.edu
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Kontakt:
- Morgan Bagley, AT, ATC, PhD
- Telefonní číslo: 330-941-3650
- E-mail: mcbagley@ysu.edu
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Dílčí vyšetřovatel:
- Alan Koren, AT, ATC, MS
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Dílčí vyšetřovatel:
- Omar Ross, PT, DPT
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Non-Probability Sample was utilized which included a sample of convenience drawn from the current cohort of YSU PT and AT graduate students.
Graduate students currently enrolled in the Youngstown State University Doctor of Physical Therapy (DPT) program or the Master of Athletic Training (MAT) program who are concurrently receiving auscultation instruction as part of their standard curriculum.
Inclusion Criteria:
- Currently enrolled in the YSU PT (DPT) or AT (MAT) professional program
- Enrolled in Human Anatomy PHYT 8810 (PT) or Human Anatomy MAT 6908 (AT), in which auscultation instruction is delivered
- Age 18 years or older
- Able to provide voluntary written informed consent
Exclusion Criteria:
- Prior formal clinical auscultation training as part of a prior healthcare degree (e.g., nursing, respiratory therapy, medicine, physician assistant)
- Inability to participate in both training sessions due to academic leave, course withdrawal, or scheduling conflict that cannot be reasonably accommodated
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Sequential Traditional+Ventriloscope Training
A single cohort of PT and AT students receives traditional auscultation training in summer, followed by Ventriloscope simulation stethoscope training approximately two months later.
All participants receive both interventions.
Assessments occur at T1 (pre-traditional), T2 (post-traditional), T3 (pre-Ventriloscope / 2-month retention), T4 (post-Ventriloscope), and T5 (2-month follow-up).
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Approximately 90-minute faculty-led session delivered in a skills laboratory.
Components include: (1) introduction and stethoscope device orientation; (2) didactic lecture on cardiac/pulmonary anatomy, sound generation; (3) peer cardiac auscultation practice at the four standard landmarks with standard stethoscopes; (4) peer pulmonary auscultation practice with standard stethoscopes; and (6) Q&A and wrap-up
Approximately 90-minute faculty-led session delivered in the same skills laboratory by the same instructor(s) approximately two months after the traditional session.
The Ventriloscope (Lecat's SimplySim, Canton, OH) pairs a standard-appearing stethoscope with a wireless transmitter; a trained faculty facilitator triggers pre-recorded pathologic sounds via remote when the student places the chest piece on a peer standardized patient.
Components include: (1) device orientation; (2) three-step technique and troubleshooting instruction; (3) rotation through eight pre-programmed clinical case stations; (4) post-station faculty-facilitated debrief; and (5) Q&A and wrap-up.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Auscultaqtion Knowledge Score
Časové okno: Measured at T1 (baseline, Week 0), T2 (immediately post-traditional, Week 0), T3 (~Week 8, pre-Ventriloscope retention check), T4 (immediately post-Ventriloscope, ~Week 8), and T5 (~Week 16, 2-month follow-up)
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Written multiple-choice knowledge assessment measuring clinical interpretation and procedures for auscultation, adapted with permission from Sherman et al. (2011) and revised to reflect PT and AT scope of practice.
Parallel-form versions are used across timepoints to reduce test-retest effects.
Scores are reported as percent correct (0-100).
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Measured at T1 (baseline, Week 0), T2 (immediately post-traditional, Week 0), T3 (~Week 8, pre-Ventriloscope retention check), T4 (immediately post-Ventriloscope, ~Week 8), and T5 (~Week 16, 2-month follow-up)
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Clinical Sound Recognition Skill Score
Časové okno: Measured at T1, T2, T3, T4, and T5 (same schedule as the knowledge outcome; spanning approximately 16 weeks)
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Structured 16-item practical assessment (7 cardiac: 3 normal, 4 abnormal; 9 pulmonary: 3 normal, 6 abnormal) in which students listen to standardized audio presentations blinded to training condition and identify sound type and normal/abnormal clinical significance.
Items scored dichotomously (1 = correct, 0 = incorrect); total score range 0-16.
Item order randomized at each administration.
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Measured at T1, T2, T3, T4, and T5 (same schedule as the knowledge outcome; spanning approximately 16 weeks)
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Self-Reported Auscultation Confidence
Časové okno: Measured at T1, T2, T3, T4, and T5 (spanning approximately 16 weeks)
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9-item Likert-scale survey (1 = Not at all confident to 5 = Extremely confident) adapted from Sherman et al. (2011) and Vatwani et al. (2023), measuring confidence across four domains: (a) performing auscultation technique, (b) identifying normal heart and lung sounds, (c) identifying abnormal heart and lung sounds, and (d) applying auscultation findings in a clinical context, with additional items addressing PT/AT scope-of-practice considerations.
Total score reported as mean item response.
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Measured at T1, T2, T3, T4, and T5 (spanning approximately 16 weeks)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Student Perceptions of Training Modalities (Qualitative)
Časové okno: Measured at T4 (immediately post-Ventriloscope, ~Week 8) and T5 (2-month follow-up, ~Week 16)
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Open-ended questionnaire asking participants to describe and compare their experiences with traditional and Ventriloscope training across four domains: perceived realism, engagement, clinical relevance, and perceived impact on clinical readiness.
Responses analyzed via conventional content analysis (Hsieh & Shannon, 2005) with two independent coders; inter-rater reliability calculated using Cohen's kappa (target > 0.70).
Outcome reported as thematic categories with frequency and representative de-identified quotes.
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Measured at T4 (immediately post-Ventriloscope, ~Week 8) and T5 (2-month follow-up, ~Week 16)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Edmund Ickert, PT, DPT, PhD, Youngstown State University
Publikace a užitečné odkazy
Obecné publikace
- Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
- Chan F, Lee J, Lu AH, Gokarn L, Rainkie D. Using simulation stethoscopes to support physical exam skill development in health professionals education: A scoping review of educational applications and outcomes. Curr Pharm Teach Learn. 2025 Dec;17(12):102466. doi: 10.1016/j.cptl.2025.102466. Epub 2025 Sep 12.
- Sherman JJ, Riche DM, Stover KR. Physical assessment experience in a problem-based learning course. Am J Pharm Educ. 2011 Oct 10;75(8):156. doi: 10.5688/ajpe758156.
- Vatwani, A., Morris, M., Hill, C., & Fernandez-Fernandez, A. (2023). Does Training with a Simulation Stethoscope Facilitate theAcquisition of Cardiopulmonary Knowledge and Confidence in Doctor of Physical Therapy Students. Internet Journal of AlliedHealth Sciences and Practice.
- Simon EL, Lecat PJ, Haller NA, Williams CJ, Martin SW, Carney JA, Pakiela JA. Improved auscultation skills in paramedic students using a modified stethoscope. J Emerg Med. 2012 Dec;43(6):1091-7. doi: 10.1016/j.jemermed.2012.01.048. Epub 2012 May 24.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
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