EffectS of prEferred Music on Laparoscopic performancE

Laparoscopic Surgery Clinical Trial

— EnSEMbLE  

Official title:

The Effect of Preferred Music on Laparoscopic Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111679
• Other study ID #: MEC-2018-1134
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: November 2019
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Surgery
• Music
• Surgical Education

Intervention

Other:
• Music
Participant selected music, applied using noise cancelling headphones

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to task completion (s)	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.	This will be measured during the experimental session which will take up about 1 hour in total
Secondary	Path length	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.	This will be measured during the experimental session which will take up about 1 hour in total
Secondary	Normalized jerk	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.	This will be measured during the experimental session which will take up about 1 hour in total
Secondary	Mental workload	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.	This will be measured during the experimental session which will take up about 1 hour in total
Secondary	Heart rate	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	This will be measured during the experimental session which will take up about 1 hour in total
Secondary	Blood pressure	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	This will be measured during the experimental session which will take up about 1 hour in total
Secondary	Participant's characteristics	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.	This will be measured during the experimental session which will take up about 1 hour in total