The Effect of Preferred Music on Laparoscopic Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time to task completion (s)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Time to task completion (s)
时间窗: This will be measured during the experimental session which will take up about 1 hour in total
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.
次要结局
- 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)
- Participant's characteristics(This will be measured during the experimental session which will take up about 1 hour in total)
研究者
Prof. dr. Gert-Jan Kleinrensink
Professor of anatomy
Erasmus Medical Center