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Work Breaks During Simulated Minimally Invasive Surgery

26 agosto 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

21

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: No breaks
Subjects will simulate a 90-min laparoscopic activities in the laboratory.
Sperimentale: 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.
Comportamentale: 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).
Altri nomi:
  • passive break
  • active break
Sperimentale: 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.
Comportamentale: 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).
Altri nomi:
  • passive break
  • active break

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rating of perceived discomfort
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Root-mean-square of electrical muscle activity recordings using electromyography
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital Tuebingen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 marzo 2019

Completamento primario (Effettivo)

14 ottobre 2020

Completamento dello studio (Effettivo)

14 ottobre 2020

Date di iscrizione allo studio

Primo inviato

26 settembre 2018

Primo inviato che soddisfa i criteri di controllo qualità

22 ottobre 2018

Primo Inserito (Effettivo)

23 ottobre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 settembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 agosto 2021

Ultimo verificato

1 agosto 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • UKT-2018AS0-1835

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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