No registrations found.
ID
Source
Brief title
Health condition
Not applicable
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to investigate the effect of participant-preferred music on laparoscopic task performance as defined by time to task completion.
Secondary outcome
Secondary Objectives are to assess the he effect of participant-preferred music on:
- Laparoscopic path length (m)
- Jerk (m/s^3)
- Economy of motion (path length/time to task completion)
- Error score
- Subjective mental workload (SURG-TLX)
- Objective mental workload (HRV)
Background summary
Rationale: The effect of recorded music on laparoscopic surgical performance and mental workload has varying reported results. This crossover study will investigate the effects of participant-preferred music on laparoscopic task performance and mental workload.
Objective: The objective is to investigate whether listening to recorded participant-preferred music has a positive effect on laparoscopic task performance and mental workload.
Study design: This study will be a four-sequence, four-period, two-treatment crossover study.
Study population: 90 Medical students and / or residents.
Intervention (if applicable): Participants will perform a laparoscopic task whilst listening to recorded, participant-preferred music. The control group will perform a laparoscopic task without music, but with recorded surgical background noise.
Main study parameters/endpoints: The primary endpoint is laparoscopic task performance as defined by time to task completion. Secondary endpoints are additional laparoscopic task performance parameters (path length, jerk, economy of motion and error score), subjective mental workload (SURG-TLX) and objective mental workload (heart rate variability).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Music has no known deleterious effects. The music volume will be limited in order to prevent noise induced hearing loss.
Study objective
The purpose of this study is to investigate the effect of recorded music on surgical task performance and mental workload in a simulated setting. The study hypothesis is that preferred music will improve surgical task performance and decrease mental workload
Study design
Start inclusion 01-09-2019, end inclusion 31-12-2019, data analysis finished 01-02-2020, manuscript draft 01-03-2020
Inclusion criteria
In order to be eligible to participate in this study a subject must meet all of the following criteria.
- Age ≥ 18 years
- Medical students and / or residents
- Provision of written informed consent by the subject.
Exclusion criteria
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), to be judged by a member of the research team.
- Use of cardiac medication
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7961 |
| Other | METC Erasmus MC : MEC-2019-0537 |