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Work Breaks During Simulated Minimally Invasive Surgery

26. august 2021 opdateret af: Dr. Tessy Luger, University Hospital Tuebingen

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Tyskland, 72074
        • Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tübingen

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: No breaks
Subjects will simulate a 90-min laparoscopic activities in the laboratory.
Eksperimentel: Passive breaks
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.
Adfærdsmæssigt: Work break schedule
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).
Andre navne:
  • passive break
  • active break
Eksperimentel: Active breaks
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.
Adfærdsmæssigt: Work break schedule
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).
Andre navne:
  • passive break
  • active break

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rating of perceived discomfort
Tidsramme: 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.
Change from baseline (0 min) to directly after (90 min) each experimental condition

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Root-mean-square of electrical muscle activity recordings using electromyography
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
Average posture over time period baseline (0 min) to end (90 min) of each experimental condition
Heart rate
Tidsramme: 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.
Average heart activity over time period baseline (0 min) to end (90 min) of each experimental condition
Work performance
Tidsramme: 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.
Change from baseline (0 min) to directly after (90 min) each experimental condition
Workload
Tidsramme: 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).
Assessed at 90 min, directly after each experimental condition
Participant evaluation
Tidsramme: 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]).
Assessed at 90 min, directly after the experimental conditions with intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital Tuebingen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. marts 2019

Primær færdiggørelse (Faktiske)

14. oktober 2020

Studieafslutning (Faktiske)

14. oktober 2020

Datoer for studieregistrering

Først indsendt

26. september 2018

Først indsendt, der opfyldte QC-kriterier

22. oktober 2018

Først opslået (Faktiske)

23. oktober 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • UKT-2018AS0-1835

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