NCT07639788

Brief Summary

In this experimental crossover study using the da Vinci simulator, the aim is to investigate how classical music influences the surgical performance of medical students. Following a brief training phase, participants complete standardized tasks under two conditions (no music vs. classical music). Performance is assessed using an objective trainer score. The study is conducted in a risk-free simulation environment, the stimuli are standardized, participation is voluntary, and data are collected in a pseudonymized manner. The goal is to obtain evidence-based insights into the effects of music and distraction on training and the working environment in robotic surgery.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress13%
May 2026Dec 2026

First Submitted

Initial submission to the registry

May 19, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 20, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 10, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 19, 2026

Last Update Submit

June 6, 2026

Conditions

Keywords

operating roomda vincirobotic surgerymusic exposuresurgical performancemedial studentsmusic listening interventionrobotic surgery simulation training

Outcome Measures

Primary Outcomes (1)

  • Da Vinci Surgical Performance Score

    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.

Secondary Outcomes (2)

  • Subjective Performance Score 1

    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

    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.

Study Arms (2)

No music exposure while performing standardize exercises

NO INTERVENTION

After a short training phase, participants perform the standardized exercises on the da Vinci simulator without any background music.

Classical Music exposure while performing standardize exercises

ACTIVE COMPARATOR

After a short training phase, participants perform the standardized exercises on the da Vinci simulator while listening to classical music.

Behavioral: Exposure to Classical Music

Interventions

Exposure to Classical Music through headphones while performing standardized exercises on the da Vinci robotic surgery simulator.

Classical Music exposure while performing standardize exercises

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ao.Univ.-Prof. Dr.med.univ. René Wenzl, MSc., Head of Endometriosis Center

Study Record Dates

First Submitted

May 19, 2026

First Posted

June 10, 2026

Study Start

May 20, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 10, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations