StressNCT00311285
Physical and Mental Load in the Surgeon Performing Laparoscopic Tasks
A study testing Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry in people with Stress, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
Trial summary
The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 2 sitesDenmark
- Study dates
- Start not givento Mar 2007
- 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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy doctors
Who cannot join
- Pregnancy
- Left handed
- Endocrine disease
- Cardiac rhythm disturbances
- History of recent injury in shoulder/arms
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
UHGentofte
Hellerup, 2100
UHGentofte
Hellerup, 2900
Helga R Munch-Petersen, MD
About this study
Official title: Physical and Mental Load During Laparoscopic Tasks. A Prospective Randomized Trial of the Ergonomics in a Black Box Model
The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. The purpose is to establish a model of how to measure mental and physical load in laparoscopy.
Read the detailed description
The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. Most studies have been conducted in laboratory set-ups: Black Box.
This study will establish a model of how to measure the biomechanical loads at muscular, joint and postural level, as well as measuring stress-hormone and cardiac rhythm. The study is a precursor of ergonomic studies performed inside the operating room. Advanced operating rooms designed specially for laparoscopy have been introduced in many departments. We do not know if they are more ergonomically correct. We will simulate laparoscopic tasks in an operating room. The hypothesis is that a traditional laparoscopic set-up is more demanding than a set-up mimicking an advanced operating room.
- Conditions
- Stress
- Being tested
- Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry
- Keywords
- Electromyography, Glucocorticoids, Heart Rate, Physical workload, Mental workload, Ergonomics, Laparoscopy, Workload, Biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometryDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG
Goniometry
Inclinometry
HRV
Salivary Cortisol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Helga R Munch-Petersen, MD, Principal investigator, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311285
- Sponsor's protocol ID
- BB-001-G-2006
- Status last verified
- Mar 2006
- First submitted
- 3 Apr 2006
- Last updated
- 2 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Mental Load During Laparoscopic Tasks. A Prospective Randomized Trial of the Ergonomics in a Black Box Model
- ClinicalTrials.gov ID
- NCT00311285
- Acronym / sponsor ID
- BB-001-G-2006
- Conditions
- Stress
- Keywords
- Electromyography, Glucocorticoids, Heart Rate, Physical workload, Mental workload, Ergonomics, Laparoscopy, Workload
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study completion
- Mar 2007
- First posted
- 5 Apr 2006 (estimated)
- 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.
The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. The purpose is to establish a model of how to measure mental and physical load in laparoscopy.
Detailed description
The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. Most studies have been conducted in laboratory set-ups: Black Box.
This study will establish a model of how to measure the biomechanical loads at muscular, joint and postural level, as well as measuring stress-hormone and cardiac rhythm. The study is a precursor of ergonomic studies performed inside the operating room. Advanced operating rooms designed specially for laparoscopy have been introduced in many departments. We do not know if they are more ergonomically correct. We will simulate laparoscopic tasks in an operating room. The hypothesis is that a traditional laparoscopic set-up is more demanding than a set-up mimicking an advanced operating room.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy doctors
Key exclusion criteria (5 listed)
- Pregnancy
- Left handed
- Endocrine disease
- Cardiac rhythm disturbances
- History of recent injury in shoulder/arms
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 |
|---|---|---|
| Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry | Device | – |
Primary outcome
EMG
Goniometry
Inclinometry
HRV
Salivary Cortisol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2007.
Related trials for Stress
Active, not recruiting
TMS-fNIRS Personalized Dosing
Post Traumatic Stress Disorder, Traumatic Brain Injury
RecruitingObservational study
Midwest Birth Outcomes and Indigenous American Pregnancy
Pregnancy
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
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.
Helga R Munch-Petersen, MD principal investigator
University Hospital, Gentofte, Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry in people with Stress, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helga R Munch-Petersen, MD (+45 39 77 33 99, hemupe04@gentoftehosp.kbhamt.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2007.