Work Breaks During Simulated Minimally Invasive Surgery
26 août 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
21
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Baden-Württemberg
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Tübingen, Baden-Württemberg, Allemagne, 72074
- Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tübingen
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: No breaks
Subjects will simulate a 90-min laparoscopic activities in the laboratory.
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Expérimental: 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.
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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).
Autres noms:
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Expérimental: 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.
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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).
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Rating of perceived discomfort
Délai: Change from baseline (0 min) to directly after (90 min) each experimental condition
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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.
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Change from baseline (0 min) to directly after (90 min) each experimental condition
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Root-mean-square of electrical muscle activity recordings using electromyography
Délai: Average root-mean-square of muscle activity over the time period running from baseline (0 min) to directly after (90 min) each experimental condition
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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.
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Average root-mean-square of muscle activity over the time period running from baseline (0 min) to directly after (90 min) each experimental condition
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Median power frequency of electrical muscle activity recordings using electromyography
Délai: 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.
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Average median power frequency f muscle activity over the time period running from baseline (0 min) to directly after (90 min) each experimental condition
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Posture of the spine / back
Délai: Average posture over time period baseline (0 min) to end (90 min) of each experimental condition
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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.
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Average posture over time period baseline (0 min) to end (90 min) of each experimental condition
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Heart rate
Délai: Average heart activity over time period baseline (0 min) to end (90 min) of each experimental condition
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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.
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Average heart activity over time period baseline (0 min) to end (90 min) of each experimental condition
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Work performance
Délai: Change from baseline (0 min) to directly after (90 min) each experimental condition
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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.
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Change from baseline (0 min) to directly after (90 min) each experimental condition
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Workload
Délai: Assessed at 90 min, directly after each experimental condition
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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).
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Assessed at 90 min, directly after each experimental condition
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Participant evaluation
Délai: Assessed at 90 min, directly after the experimental conditions with intervention
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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]).
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Assessed at 90 min, directly after the experimental conditions with intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 mars 2019
Achèvement primaire (Réel)
14 octobre 2020
Achèvement de l'étude (Réel)
14 octobre 2020
Dates d'inscription aux études
Première soumission
26 septembre 2018
Première soumission répondant aux critères de contrôle qualité
22 octobre 2018
Première publication (Réel)
23 octobre 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 septembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2021
Dernière vérification
1 août 2021
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- UKT-2018AS0-1835
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .