- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07639788
The Impact of Classical Music on Performance in Robotic Surgery Simulation
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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State of Vienna
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Vienna, State of Vienna, Østerrike, 1090
- Medical University of Vienna
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Da Vinci Surgical Performance Score
Tidsramme: 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.
|
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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective Performance Score 1
Tidsramme: 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.
|
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.
|
|
Subjective Performance Score 2
Tidsramme: 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.
|
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.
|
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.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
Nøkkelord
Andre studie-ID-numre
- 1041/2026
Plan for individuelle deltakerdata (IPD)
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Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .