EffectS of prEferred Music on Laparoscopic performancE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Laparoscopic Surgery Music Surgical Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This will be a 4-period 4-sequence 2-treatment crossover study, participants will be exposed to both control group (A), the silent group, and intervention group (B), the music group, whilst performing a laparoscopic task in a box trainer.

Participants will be randomly assigned to a sequence that determines in which order they are being exposed to both auditory environments

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Music

During laparoscopic task performance; participants will wear a noise cancelling headphone that plays music that is chosen by the participant.

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Participant selected music, applied using noise cancelling headphones

No music

During laparoscopic task performance; participants will wear a noise cancelling headphone that does not play music.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music

Participant selected music, applied using noise cancelling headphones

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes