Work Breaks During Simulated Minimally Invasive Surgery
26. august 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
21
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Baden-Württemberg
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Tübingen, Baden-Württemberg, Tyskland, 72074
- Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tübingen
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: No breaks
Subjects will simulate a 90-min laparoscopic activities in the laboratory.
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Eksperimentell: 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).
Andre navn:
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Eksperimentell: 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).
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Rating of perceived discomfort
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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
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
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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 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Sponsor
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. mars 2019
Primær fullføring (Faktiske)
14. oktober 2020
Studiet fullført (Faktiske)
14. oktober 2020
Datoer for studieregistrering
Først innsendt
26. september 2018
Først innsendt som oppfylte QC-kriteriene
22. oktober 2018
Først lagt ut (Faktiske)
23. oktober 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- UKT-2018AS0-1835
Plan for individuelle deltakerdata (IPD)
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NEI
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Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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