EffectS of prEferred Music on Laparoscopic performancE (EnSEMbLE)
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About
The main objective is to investigate whether listening to recorded music has a positive effect on the execution of laparoscopic skills.
Secondary objectives are to investigate the effects of music during surgical performance on blood pressure, mental workload and heart rate.
Study design: This will be a 4-period 4-sequence 2-treatment crossover study, participants will be exposed to both control (noise cancelling headphones without music) and the intervention (preferred music via headphones) whilst performing a laparoscopic task in a box trainer. Every period consists of 5 repetitions of a laparoscopic peg transfer task. In total participants will perform in each condition 10 peg transfer tasks.
Prior to the experiment, all participants practice the laparoscopic peg transfer task 20 times
Study population: Healthy volunteering medicine students without laparoscopic experience.
Intervention (if applicable): Participants will perform 2 periods of 5 laparoscopic peg transfer task whilst listening to preferred recorded music via headphones and 2 periods of 5 laparoscopic peg transfer tasks while wearing noise cancelling headphones without music (2 periods of 5 tasks).
Main study parameters/endpoints: The primary endpoint is laparoscopic performance as defined by time of task completion Secondary endpoints are: laparoscopic task performance (path length, jerk, error score, economy of motion) vital parameters (heart rate, and post test blood pressure) and mental workload (SURG-TLX)
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Inclusion and exclusion criteria
Inclusion Criteria:
In order to be eligible to participate in this study a subject must meet all of the following criteria.
- Age ≥ 18 years
- Medicine students
- Provision of written informed consent by the subject.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Severe hearing impairment, defined as no verbal communication possible.
- Severe visual impairment, defined as not able to see the monitor on which the laparoscopic task is projected.
- Any physical handicap that impairs laparoscopic performance (unable to stand for 10 minutes, unable to hold and use both instruments.
Trial design
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Allocation
Interventional model
Masking
60 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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