Work Breaks During Simulated Minimally Invasive Surgery
2021년 8월 26일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
21
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Baden-Württemberg
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Tübingen, Baden-Württemberg, 독일, 72074
- Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tübingen
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: No breaks
Subjects will simulate a 90-min laparoscopic activities in the laboratory.
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실험적: 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).
다른 이름들:
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실험적: 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).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Rating of perceived discomfort
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Root-mean-square of electrical muscle activity recordings using electromyography
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 3월 18일
기본 완료 (실제)
2020년 10월 14일
연구 완료 (실제)
2020년 10월 14일
연구 등록 날짜
최초 제출
2018년 9월 26일
QC 기준을 충족하는 최초 제출
2018년 10월 22일
처음 게시됨 (실제)
2018년 10월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 9월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 8월 26일
마지막으로 확인됨
2021년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- UKT-2018AS0-1835
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
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아니
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아니
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