Work Breaks During Simulated Minimally Invasive Surgery

NCT03715816 | Completed DMC

• 1 other identifier: UKT-2018AS0-1835
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Work-break Schedules

Keywords

endoscopy; minimally invasive surgery; passive breaks; active breaks; muscle activity; back curvature

Outcome Measures

Primary Outcomes (1)

• Rating of perceived discomfort

  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.

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

Secondary Outcomes (7)

• 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

• 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

• Heart rate

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

• Work performance

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

Study Arms (3)

No breaks

NO INTERVENTION

Subjects will simulate a 90-min laparoscopic activities in the laboratory.

Passive breaks

EXPERIMENTAL

Subjects will simulate a 90-min laparoscopic activities in the laboratory, and after 30 and 60 min of work, they will be provided a 2.5-min break during which they can have a rest.

Behavioral: Work break schedule

Active breaks

EXPERIMENTAL

Subjects will simulate a 90-min laparoscopic activities in the laboratory, and after 30 and 60 min of work, they will be provided a 2.5-min break during which they will be performing some mobilisation exercises for the back, shoulder, and neck.

Behavioral: Work break schedule

Interventions

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).

Also known as: passive break, active break

Active breaks; Passive breaks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

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

Tübingen, Baden-Wurttemberg, 72074, Germany

Location

Related Publications (2)

• 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.

  PMID: 33444192 BACKGROUND

• Luger T, Bonsch R, Seibt R, Kramer B, Rieger MA, Steinhilber B. Intraoperative active and passive breaks during minimally invasive surgery influence upper extremity physical strain and physical stress response-A controlled, randomized cross-over, laboratory trial. Surg Endosc. 2023 Aug;37(8):5975-5988. doi: 10.1007/s00464-023-10042-9. Epub 2023 Apr 21.

  PMID: 37084097 DERIVED

Related Links

• Homepage of the responsible Institute
• Page 285: poster presentation with preliminary results presented at the PREMUS 2019 conference in Bologna, Italy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 23, 2018
• Study Start: March 18, 2019
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)