- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07639788
The Impact of Classical Music on Performance in Robotic Surgery Simulation
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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State of Vienna
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Vienna, State of Vienna, Austria, 1090
- Medical University of Vienna
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
The study includes adult (≥ 18 years) medical students between the first completed and the twelfth completed semester. Prior experience in robotic surgery or with training simulators is not required; however, basic familiarity with the use of technical devices is necessary. Furthermore, participants must have sufficient knowledge of German or English to provide informed consent and fully understand the instructions.
Exclusion Criteria:
- Lack of capacity to provide informed consent
- Insufficient language proficiency (German/English)
- Known hypersensitivity to noise
- Hearing or balance disorders
- Conditions that significantly affect attention or motor skills (e.g., tremor, myopathies)
- Acute illnesses that may impair participation, substance influence, or severe fatigue
- Direct dependency or evaluative relationship with members of the study team
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: No music exposure while performing standardize exercises
After a short training phase, participants perform the standardized exercises on the da Vinci simulator without any background music.
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Comparador activo: Classical Music exposure while performing standardize exercises
After a short training phase, participants perform the standardized exercises on the da Vinci simulator while listening to classical music.
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Exposure to Classical Music through headphones while performing standardized exercises on the da Vinci robotic surgery simulator.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Da Vinci Surgical Performance Score
Periodo de tiempo: Once after each cycle (estimated: 15 minutes per cycle) of performing the standardized simulated surgical tasks (once with and once without exposure to Classical Music), the Performance Score will be measured by the simulation system.
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The primary outcome measure reflects the objective performance in the robotic da Vinci simulator and is automatically calculated by the simulation system based on parameters including total task completion time, error rate, and task precision.
A higher score indicates a better performance during the task.
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Once after each cycle (estimated: 15 minutes per cycle) of performing the standardized simulated surgical tasks (once with and once without exposure to Classical Music), the Performance Score will be measured by the simulation system.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subjective Performance Score 1
Periodo de tiempo: After each cycle (estimated: 15 minutes per cycle)of performing the standardized simulated surgical tasks (once with and once without exposure to Classical Music), the Subjective Performance Score will be measured by the SURG-TLX.
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Subjective measures of workload and perception are collected by using the SURG-TLX questionnaire (including subscales for mental and physical workload, time pressure, task complexity, stress, and distraction) including 6 questions (0-21 points per question) with a minimum of 0 and a maximum of 126 points.
A lower score indicates better subjective performance.
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After each cycle (estimated: 15 minutes per cycle)of performing the standardized simulated surgical tasks (once with and once without exposure to Classical Music), the Subjective Performance Score will be measured by the SURG-TLX.
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Subjective Performance Score 2
Periodo de tiempo: After each cycle (estimated: 15 minutes per cycle) of performing the standardized simulated surgical tasks (once with and once without exposure to Classical Music), the Subjective Performance Score will be measured by the additional questionnaire.
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Subjective measures of workload and perception are collected by using an additional questionnaire for a brief self-assessment of concentration and perceived distraction including 3 questions (0-10 points per question) with a minimum of 0 and a maximum of 30 points.
A higher score indicates better subjective performance.
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After each cycle (estimated: 15 minutes per cycle) of performing the standardized simulated surgical tasks (once with and once without exposure to Classical Music), the Subjective Performance Score will be measured by the additional questionnaire.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1041/2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .