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EffectS of prEferred Music on Laparoscopic performancE

NCT04111679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-11-07

No results posted yet for this study

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)

Conditions

  • Laparoscopic Surgery
  • Music
  • Surgical Education

Interventions

OTHER

Music

Participant selected music, applied using noise cancelling headphones

Sponsors & Collaborators

Principal Investigators

  • Gert-Jan Kleinrensink, Prof. Dr. · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04111679 on ClinicalTrials.gov