Clinical trial NCT03715816: Work Breaks During Simulated Minimally Invasive Surgery
Official title: Work Breaks During Minimally Invasive Surgery - Target-group Specific Development of Work Break Schedules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Work-break Schedules
Keywords: endoscopy
minimally invasive surgery
passive breaks
active breaks
muscle activity
back curvature
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Rating of perceived discomfort
timeFrame: Change from baseline (0 min) to directly after (90 min) each experimental condition
Secondary outcomes:
measure: Root-mean-square of electrical muscle activity recordings using electromyography
timeFrame: Average root-mean-square of muscle activity over the time period running from baseline (0 min) to directly after (90 min) each experimental condition
measure: Median power frequency of electrical muscle activity recordings using electromyography
timeFrame: Average median power frequency f muscle activity over the time period running from baseline (0 min) to directly after (90 min) each experimental condition
measure: Posture of the spine / back
timeFrame: Average posture over time period baseline (0 min) to end (90 min) of each experimental condition
measure: Heart rate
timeFrame: Average heart activity over time period baseline (0 min) to end (90 min) of each experimental condition
measure: Work performance
timeFrame: Change from baseline (0 min) to directly after (90 min) each experimental condition
measure: Workload
timeFrame: Assessed at 90 min, directly after each experimental condition
measure: Participant evaluation
timeFrame: Assessed at 90 min, directly after the experimental conditions with intervention
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tübingen
state: Baden-Württemberg
Study officials:
References:
citation: Luger T, Rieger MA, Bonsch R, Kramer B, Seibt R, Steinhilber B. Active and passive work breaks during simulated laparoscopy among laparoscopic surgeons: study protocol for a controlled, randomised cross-over laboratory trial. BMJ Open. 2020 Nov 19;10(11):e038952. doi: 10.1136/bmjopen-2020-038952.