EffectS of prEferred Music on Laparoscopic performancE

NCT04111679 | Completed

• 1 other identifier: MEC-2018-1134
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Laparoscopic Surgery; Music; Surgical Education

Keywords

Surgical skill; Music; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Path length

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

• Normalized jerk

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

• Mental workload

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

• Heart rate

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

• Blood pressure

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

Study Arms (2)

Music

EXPERIMENTAL

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

Other: Music

No music

NO INTERVENTION

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

Interventions

Music OTHER

Participant selected music, applied using noise cancelling headphones

Music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 32333159 DERIVED

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gert-Jan Kleinrensink, Prof. Dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anatomy

Model Details: 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

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: October 1, 2019
• Study Start: June 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: November 7, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)