Musculoskeletal StrainNCT03096769
Ergonomics in Robotic Surgery
A study testing Ergonomist in people with Musculoskeletal Strain and Ergonomics, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is designed to answer if an ergonomist can configure a daVinci robot console to improve surgeon discomfort. Adjustments to the robot console will be surgeon specific as they are tailored to their individual body type. Measurements will be taken at the time of console configuration. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Strain, Ergonomics
- What is being tested?
- Ergonomist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2017to 31 Aug 2017
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fellowship trained, specialty board certified gynecologic surgeon.
- Robot used for hysterectomy until completion of vaginal cuff closure.
Who cannot join
- Any non-robotic method to perform hysterectomy (laparotomy, non-robotic laparoscopic, vaginal approach).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study is designed to answer if an ergonomist can configure a daVinci robot console to improve surgeon discomfort. Adjustments to the robot console will be surgeon specific as they are tailored to their individual body type. Measurements will be taken at the time of console configuration.
- Conditions
- Musculoskeletal Strain, Ergonomics
- Being tested
- Ergonomist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgonomistOther
The intervention consists of each surgeon meeting with an ergonomist where the ergonomist will adjust the console settings and chair height to an ergonomically optimal position.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Other | Not described Receives: Other: Ergonomist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nordic Upper Body Questionnaire Score
The Nordic upper body questionnaire will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy.
Measured: Baseline, Immediately postoperative (approximately one hour)
Change in Body Part Discomfort Questionnaire Score
The Body Part Discomfort Questionnaire will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy
Measured: Baseline, Immediately postoperative (approximately one hour)
Surgical Task Load Index Score
The surgical task load index score will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy.
Measured: Immediately postoperative (approximately one hour)
Secondary outcomes (2)
Change in measurement of console settings (in cm)
Comparison between surgeon- and ergonomist-derived console settings
Measured: Baseline, up to 1 year
Change in measurement of console head angle (in degrees)
Comparison between surgeon- and ergonomist-derived console settings
Measured: Baseline, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start2 Feb 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal StrainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John A. Occhino, Mayo Clinic
- Investigators
- John A Occhino, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096769
- Sponsor's protocol ID
- 16-009275
- Status last verified
- Mar 2018
- First submitted
- 21 Mar 2017
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergonomics in Robotic Surgery
- ClinicalTrials.gov ID
- NCT03096769
- Acronym / sponsor ID
- 16-009275
- Conditions
- Musculoskeletal Strain, Ergonomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 30 Mar 2017 (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.
This study is designed to answer if an ergonomist can configure a daVinci robot console to improve surgeon discomfort. Adjustments to the robot console will be surgeon specific as they are tailored to their individual body type. Measurements will be taken at the time of console configuration.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Other | Other: Ergonomist |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fellowship trained, specialty board certified gynecologic surgeon.
- Robot used for hysterectomy until completion of vaginal cuff closure.
Key exclusion criteria (1 listed)
- Any non-robotic method to perform hysterectomy (laparotomy, non-robotic laparoscopic, vaginal approach).
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 |
|---|---|---|
| ErgonomistThe intervention consists of each surgeon meeting with an ergonomist where the ergonomist will adjust the console settings and chair height to an ergonomically optimal position. | Other | Study Arm |
Primary outcome
Change in Nordic Upper Body Questionnaire Score
Time frame: Baseline, Immediately postoperative (approximately one hour)
The Nordic upper body questionnaire will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy.
Change in Body Part Discomfort Questionnaire Score
Time frame: Baseline, Immediately postoperative (approximately one hour)
The Body Part Discomfort Questionnaire will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy
Surgical Task Load Index Score
Time frame: Immediately postoperative (approximately one hour)
The surgical task load index score will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy.
2 secondary outcomes
Change in measurement of console settings (in cm)
Time frame: Baseline, up to 1 year
Change in measurement of console head angle (in degrees)
Time frame: Baseline, up to 1 year
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 21 Mar 2018.
- Individual participant dataSharing planned: No
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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.
John A Occhino principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergonomist in people with Musculoskeletal Strain and Ergonomics, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 1 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 21 Mar 2018. 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 United States. 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?
Change in Nordic Upper Body Questionnaire Score (time frame: Baseline, Immediately postoperative (approximately one hour)). The study lists 3 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 21 Mar 2018.