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临床试验/NCT03715816
NCT03715816已完成不适用

Work Breaks During Minimally Invasive Surgery - Target-group Specific Development of Work Break Schedules

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2019年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Rating of perceived discomfort

研究概览

简要总结

Minimally invasive surgeons have a prevalence of work-related musculoskeletal complaints of up to 86% due to the exposure to static loading, awkward postures, work pressure, and patient's wellbeing. Researchers have developed postural interventions to counteract the prevalence of musculoskeletal complaints and disorders, such as robot-assisted surgeries, arm-support systems, and rotatable handle pieces. An alternative intervention is to implement work breaks during the surgeries, which has shown to give promising results including that surgery duration does not prolong.

The aim of the current study is to simulate 90-min laparoscopic surgery activities in the laboratory and compare two intervention situations with the control situation. The control situation is without work breaks. The two intervention situations include 2.5-min breaks provided two times, i.e. after every 30-min work period, which are passive (rest) or active (targeted mobilization exercises). The assessment is based on changes in muscular activity on the back and upper extremities, back and upper extremity postures, feelings of discomfort, and work performance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

盲法说明

The study is not blinded, because the subject(s) will know which of the three experimental conditions they are exposed to (control without breaks; intervention with passive or active breaks). The same applies to the experimenter(s).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (Student) surgeons, who are familiar with laparoscopic procedures and / or simulated laparoscopic procedures;
  • Be able to perform the Peg-Transfer task (Simulab, Seattle, WA, USA) within 3 minutes;
  • The participant will give her/his voluntary informed consent after receiving oral and written information of the content and goal of the study.

排除标准

  • (Student) surgeons who are not familiar with laparoscopic procedures and / or simulated laparoscopic procedures;
  • Not able to perform the Peg-Transfer task within 3 minutes;
  • People under the influence of intoxicants, analgesics, or muscle relaxants;
  • Alcohol abuse;
  • People with cardiovascular diseases;
  • People with a heart pacemaker;
  • People with a disability who, due to their restriction at a workplace of this kind, will not be able to participate;
  • People with Diabetes Mellitus;
  • People with severe muscle contractions of the lower extremities, back or arms;
  • People with acute ailments or pain, which make(s) them unable to participate;
  • People who are unable to complete the examination program due to language or cognitive obstacles;
  • Depending on the degree of severity, people with diseases of the veins and joints of the lower extremities, spine, muscle disorders, symptomatic neurological-psychiatric diseases, acute pain syndromes, maladies or other current diseases.

结局指标

主要结局

Rating of perceived discomfort

时间窗: Change from baseline (0 min) to directly after (90 min) each experimental condition

Discomfort will be assessed using an 11-point numeric rating scale, ranging from 0 (no discomfort at all) to 10 (maximally imaginable discomfort). It will be assessed directly before and directly after each experimental condition.

次要结局

  • Heart rate(Average heart activity over time period baseline (0 min) to end (90 min) of each experimental condition)
  • Root-mean-square of electrical muscle activity recordings using electromyography(Average root-mean-square of muscle activity over the time period running from baseline (0 min) to directly after (90 min) each experimental condition)
  • Work performance(Change from baseline (0 min) to directly after (90 min) each experimental condition)
  • Participant evaluation(Assessed at 90 min, directly after the experimental conditions with intervention)
  • Median power frequency of electrical muscle activity recordings using electromyography(Average median power frequency f muscle activity over the time period running from baseline (0 min) to directly after (90 min) each experimental condition)
  • Posture of the spine / back(Average posture over time period baseline (0 min) to end (90 min) of each experimental condition)
  • Workload(Assessed at 90 min, directly after each experimental condition)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Tessy Luger

Principal Investigator

University Hospital Tuebingen

研究点 (2)

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