Work-break SchedulesNCT03715816

Work Breaks During Simulated Minimally Invasive Surgery

A study testing Work break schedule in people with Work-break Schedules, run by University Hospital Tuebingen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Work-break Schedules
What is being tested?: Work break schedule
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteGermany
Study dates: 18 Mar 2019to 14 Oct 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

(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.

Who cannot join

(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;

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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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

Other trials in Germany

About this study

Official title: 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.

Conditions: Work-break Schedules
Being tested: Work break schedule
Keywords: endoscopy, minimally invasive surgery, passive breaks, active breaks, muscle activity, back curvature

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Work break scheduleBehavioural
Also called passive break, active break
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).

Study groups in NCT03715816
Study group	Role	What they receive
No breaks	No intervention	Subjects will simulate a 90-min laparoscopic activities in the laboratory.
Passive breaks	Experimental	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. Receives: Behavioral: Work break schedule
Active breaks	Experimental	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. Receives: Behavioral: Work break schedule

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 201914 Oct 2020

First posted23 Oct 2018
Study start18 Mar 2019
Primary completion14 Oct 2020
Study completion14 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Work-break SchedulesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03715816
Sponsor's protocol ID: UKT-2018AS0-1835
Status last verified: Aug 2021
First submitted: 26 Sep 2018
Last updated: 2 Sep 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Luger T, Rieger MA, Bonsch R, Kramer B, Seibt R, Steinhilber B. Active and passive work breaks during simulated laparoscopy among laparoscopic surgeons: study protocol for a controlled, randomised cross-over laboratory trial. BMJ Open. 2020 Nov 19;10(11):e038952. doi: 10.1136/bmjopen-2020-038952.
PubMed 33444192
Luger T, Bonsch R, Seibt R, Kramer B, Rieger MA, Steinhilber B. Intraoperative active and passive breaks during minimally invasive surgery influence upper extremity physical strain and physical stress response-A controlled, randomized cross-over, laboratory trial. Surg Endosc. 2023 Aug;37(8):5975-5988. doi: 10.1007/s00464-023-10042-9. Epub 2023 Apr 21.
PubMed 37084097

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Work Breaks During Minimally Invasive Surgery - Target-group Specific Development of Work Break Schedules
ClinicalTrials.gov ID: NCT03715816
Acronym / sponsor ID: UKT-2018AS0-1835
Conditions: Work-break Schedules
Keywords: endoscopy, minimally invasive surgery, passive breaks, active breaks, muscle activity, back curvature
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University Hospital TuebingenUniversity, hospital or other
Study start: 18 Mar 2019 (actual)
Primary completion: 14 Oct 2020 (actual)
Study completion: 14 Oct 2020 (actual)
First posted: 23 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
No breaks	No intervention	–Subjects will simulate a 90-min laparoscopic activities in the laboratory.
Passive breaks	Experimental	Behavioral: Work break scheduleSubjects 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.
Active breaks	Experimental	Behavioral: Work break scheduleSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

(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.

Key exclusion criteria (12 listed)

(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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Work break scheduleAlso: passive break, active breakParticipants 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).	Behavioural	Active breaks, Passive breaks

Primary outcome

Rating of perceived discomfort
Time frame: 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.

7 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
Background: PubMed 33444192Luger T, Rieger MA, Bonsch R, Kramer B, Seibt R, Steinhilber B. Active and passive work breaks during simulated laparoscopy among laparoscopic surgeons: study protocol for a controlled, randomised cross-over laboratory trial. BMJ Open. 2020 Nov 19;10(11):e038952. doi: 10.1136/bmjopen-2020-038952.
Derived from this study: PubMed 37084097Luger T, Bonsch R, Seibt R, Kramer B, Rieger MA, Steinhilber B. Intraoperative active and passive breaks during minimally invasive surgery influence upper extremity physical strain and physical stress response-A controlled, randomized cross-over, laboratory trial. Surg Endosc. 2023 Aug;37(8):5975-5988. doi: 10.1007/s00464-023-10042-9. Epub 2023 Apr 21.
Homepage of the responsible InstituteLink provided by the sponsor.
Page 285: poster presentation with preliminary results presented at the PREMUS 2019 conference in Bologna, ItalyLink provided by the sponsor.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Work break schedule in people with Work-break Schedules, run by University Hospital Tuebingen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rating of perceived discomfort (time frame: Change from baseline (0 min) to directly after (90 min) each experimental condition). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03715816, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.