NCT07559422

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

May 11, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

VentriloscopeSimulation stethoscopeAuscultationPhysical therapy educationAthletic training educationSimulation-based learning

Outcome Measures

Primary Outcomes (3)

  • Auscultaqtion Knowledge Score

    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).

    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)

  • Clinical Sound Recognition Skill Score

    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.

    Measured at T1, T2, T3, T4, and T5 (same schedule as the knowledge outcome; spanning approximately 16 weeks)

  • Self-Reported Auscultation Confidence

    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.

    Measured at T1, T2, T3, T4, and T5 (spanning approximately 16 weeks)

Secondary Outcomes (1)

  • Student Perceptions of Training Modalities (Qualitative)

    Measured at T4 (immediately post-Ventriloscope, ~Week 8) and T5 (2-month follow-up, ~Week 16)

Study Arms (1)

Sequential Traditional+Ventriloscope Training

EXPERIMENTAL

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).

Behavioral: Traditional Auscultation TrainingBehavioral: Ventriloscope Simulation Training

Interventions

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

Sequential Traditional+Ventriloscope Training

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.

Sequential Traditional+Ventriloscope Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44555, United States

Location

Related Publications (5)

  • 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.

    PMID: 40945237BACKGROUND
  • 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.

    PMID: 22102746BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 22633756BACKGROUND
  • Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

    PMID: 16204405BACKGROUND

Study Officials

  • Edmund Ickert, PT, DPT, PhD

    Youngstown State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edmund Ickert, PT, DPT, PhD

CONTACT

Morgan Bagley, PhD, AT, ATC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants and training facilitators cannot be masked given the nature of the educational interventions.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single-cohort, longitudinal, within-subjects repeated-measures design. All enrolled participants receive both the traditional auscultation training intervention and the Ventriloscope simulation training intervention in sequence, with quantitative outcomes assessed at five timepoints across approximately five months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 30, 2026

Study Start (Estimated)

May 11, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 19, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. Only aggregate, de-identified data will appear in publications and presentations, consistent with the consent provided to participants and with institutional data-retention policies (5 years post-study completion).

Locations