Clinical trial NCT04111679: EffectS of prEferred Music on Laparoscopic performancE
Official title: The Effect of Preferred Music on Laparoscopic Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgery
Music
Surgical Education
Keywords: Surgical skill
Music
Laparoscopy
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: BASIC_SCIENCE

Brief 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)


Eligibility 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.

Primary outcomes:
measure: Time to task completion (s)
timeFrame: This will be measured during the experimental session which will take up about 1 hour in total
Secondary outcomes:
measure: Path length
timeFrame: This will be measured during the experimental session which will take up about 1 hour in total
measure: Normalized jerk
timeFrame: This will be measured during the experimental session which will take up about 1 hour in total
measure: Mental workload
timeFrame: This will be measured during the experimental session which will take up about 1 hour in total
measure: Heart rate
timeFrame: This will be measured during the experimental session which will take up about 1 hour in total
measure: Blood pressure
timeFrame: This will be measured during the experimental session which will take up about 1 hour in total
measure: Participant's characteristics
timeFrame: This will be measured during the experimental session which will take up about 1 hour in total
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Gert-Jan Kleinrensink, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oomens P, Fu VX, Kleinrensink VEE, Kleinrensink GJ, Jeekel J. The Effects of Preferred Music on Laparoscopic Surgical Performance: A Randomized Crossover Study. World J Surg. 2020 Aug;44(8):2614-2619. doi: 10.1007/s00268-020-05523-0.