- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07639788
The Impact of Classical Music on Performance in Robotic Surgery Simulation
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
State of Vienna
-
Vienna, State of Vienna, Austria, 1090
- Medical University of Vienna
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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.
|
|
|
Active Comparator: 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.
|
Exposure to Classical Music through headphones while performing standardized exercises on the da Vinci robotic surgery simulator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Da Vinci Surgical Performance Score
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Performance Score 1
Time Frame: 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 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
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1041/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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