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OpenTrials
Completed

NCT Number: NCT04111679

EffectS of prEferred Music on Laparoscopic performancE

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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Key information

Conditions

Laparoscopic Surgery Music Surgical Education

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music

Other

Participant selected music, applied using noise cancelling headphones

Primary outcomes

  1. Time to task completion (s)

    Time frame: This will be measured during the experimental session which will take up about 1 hour in total

    It will be measured in seconds and calculated using data generated from motion analysis software. Each tasks starts, when the participants puts the tip of the grasper in a yellow square that is projected on the screen, after task completion the participant puts tip in the square again to finish the task. The time between start and finish is defined as the time to task completion.

    An average is calculated for both the 10 tasks in the intervention group and the 10 tasks in the control group.

Secondary outcomes

  1. Path length

    Time frame: This will be measured during the experimental session which will take up about 1 hour in total

    The total distance the tip of the instrument has travelled per task (mm) per task, it will be calculated using data generated from motion analysis software. Each tasks starts, when the participants puts the tip of the grasper in a yellow square that is projected on the screen, after task completion the participant puts tip in the square again to finish the task. An average is calculated for both the 10 tasks in the intervention group and the 10 tasks in the control group.

  2. Normalized jerk

    Time frame: This will be measured during the experimental session which will take up about 1 hour in total

    the rate of change of acceleration of the instrument tips (m/s3) per task. It will be calculated using data generated from motion analysis software. Each tasks starts, when the participants puts the tip of the grasper in a yellow square that is projected on the screen, after task completion the participant puts tip in the square again to finish the task. An average is calculated for both the 10 tasks in the intervention group and the 10 tasks in the control group.

  3. Mental workload

    Time frame: This will be measured during the experimental session which will take up about 1 hour in total

    Mental workload will be assessed using the Surgery task load index (SURG-TLX) this is a validated multidimensional, surgery-specific workload measure. The SURG-TLX is an adapted version of the National Aeronautics and Space Administration Task Load Index (NASA-TLX).

    In the SURG-TLX subjects rate six dimensions of workload i.e. situational stress, distractions, task complexity, physical demands, temporal demands and mental demands on visual analogue scales VAS ranging from 0-100 (0 = very low;100 = very high) the scores of these subscales are combined into a weighed average that results in a general score ranging from 0-100 (0 = very low; 100 = very high) After every period of 5 tasks a SURG-TLX questionnaire is completed. An average is calculated for both the two periods in the intervention group and the two periods in the control group. The averages of both the general score and the individual subscales will be reported.

  4. Heart rate

    Time frame: This will be measured during the experimental session which will take up about 1 hour in total

    Heart rate will be assessed prior to; and immediately after every period of laparoscopic tasks in beats per minute. Change in heart rate before and after each period of tasks is calculated. An average change will be calculated for both the two periods in the intervention group and the two periods in the control group

  5. Blood pressure

    Time frame: This will be measured during the experimental session which will take up about 1 hour in total

    Systolic and diastolic pressure will be assessed prior to and immediately after every period of laparoscopic tasks in mmHg. Change in blood pressure before and after each period of tasks is calculated. An average change will be calculated for both the two periods in the intervention group and the two periods in the control group

  6. Participant's characteristics

    Time frame: This will be measured during the experimental session which will take up about 1 hour in total

    • Age (years)
    • Sex (male or female)
    • Dexterity (left- or right handed, ambidextrous)
    • Year of medical education:
    • The importance of music in daily life on a (10-point numeric rating scale)
    • Musical genres the subject listens to (classical, world music, rock, pop, techno, house, jazz, blues, disco, other)
    • Musical genres the subject listens to when studying: (classical, world music, rock, pop, techno, house, jazz, blues, disco, other)
    • choice of music during the experiment
    • Whether or not the subject plays or has played a musical instrument (never, in the past, currently)
    • Whether or not the subject plays or has played video games and to what extends (never, in the past, currently)

    This questionnaire will be completed before starting the practice session of 20 laparoscopic tasks.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

The Effect of Preferred Music on Laparoscopic Performance

Acronym: EnSEMbLE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2019
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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