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OpenTrials
Completed

NCT Number: NCT03715816

Work Breaks During Simulated Minimally Invasive Surgery

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.

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Key information

Conditions

Work-break Schedules

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72074, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Work break schedule

Behavioral

Participants will receive 2.5-min breaks during a 90-min simulated laparoscopic surgery in the laboratory. The breaks will be either passive (simple rest) or active (selected mobilization exercises).

Other names: passive break, active break

Primary outcomes

  1. Rating of perceived discomfort

    Time frame: 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.

Secondary outcomes

  1. Root-mean-square of electrical muscle activity recordings using electromyography

    Time frame: Average root-mean-square of muscle activity over the time period running from baseline (0 min) to directly after (90 min) each experimental condition

    Selected target muscles in the arms (deltoid acromialis, extensor digitorum, flexor carpi radialis), shoulder (trapezius descendens) and back (erector spinae lumbalis) will be continuously recorded with electromyography. From the electromyographic signal, the root-mean-square will be calculated and averaged over the time period in each experimental condition.

  2. Median power frequency of electrical muscle activity recordings using electromyography

    Time frame: Average median power frequency f muscle activity over the time period running from baseline (0 min) to directly after (90 min) each experimental condition

    Selected target muscles in the arms (deltoid acromialis, extensor digitorum, flexor carpi radialis), shoulder (trapezius descendens) and back (erector spinae lumbalis) will be continuously recorded with electromyography. From the electromyographic signal, the median power frequency will be calculated and averaged over the time period in each experimental condition.

  3. Posture of the spine / back

    Time frame: Average posture over time period baseline (0 min) to end (90 min) of each experimental condition

    Using gravimetric position sensors, the curvature of the back will be recorded as well as the head position and movement with respect to the trunk. Recordings are continuous and average angles (kyphosis, lordosis, neck angle) will be calculated per time period.

  4. Heart rate

    Time frame: Average heart activity over time period baseline (0 min) to end (90 min) of each experimental condition

    Continuous recording electrocardiography allows calculating the heart rate, a parameter reflecting the central stress state of the participant. The average heart rate will be calculated per time period.

  5. Work performance

    Time frame: Change from baseline (0 min) to directly after (90 min) each experimental condition

    Using the Peg-Transfer Board (Simulab, Seattle, WA, USA), subjects will perform this task for exaclty 1 minute. Time is recorded after one repetition is finished and final performance for the overall minute is recorded as well.

  6. Workload

    Time frame: Assessed at 90 min, directly after each experimental condition

    Using the Hart and Staveland's NASA Task Load Index (TLX) method, workload is assessed for 6 dimensions where participants put a cross on one of the 21 lines on the 21-point scales, which range from left (very satisfied; way too much; much to short; clearly increased) to right (very unsatisfied; way too few; much to long; clearly reduced).

  7. Participant evaluation

    Time frame: Assessed at 90 min, directly after the experimental conditions with intervention

    Self-developed questionnaire assessing aspects of applicability and acceptability of the tested interventions in the field. All questions will be multiple choice questions, resulting in categorical variables (scales ranging from 1 [very satisfied / true] to 4 [very unsatisfied / not true]).

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2018
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.