Musculoskeletal InjuryNCT02597959
Reducing Musculoskeletal Stresses and Work-related Injuries Among Allied Health Professionals in Surgical Care
An observational study of Musculoskeletal Injury and Musculoskeletal Illness, run by Mayo Clinic at 1 site in United States.
Trial summary
1. What are the risk factors that contribute to musculoskeletal injuries and fatigue on allied health professionals in surgical care (e.g. scrub nurses, surgical assistants, and circulating nurses)? 2. Can the investigators design wearable devices that the investigators can later evaluate? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Injury, Musculoskeletal Illness
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2016
- Phase
- Observational
- 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
Study population: Surgical Assistants, Circulating Nurses, and Scrub Nurses (Surgical Technicians) employed at Mayo Clinic Rochester, MN, are the subjects for Aims 1 and 2. The subject population for the future Aim 3 includes surgical assistant anatomy laboratory students enrolled through the Mayo School of Health Sciences Surgical First Assistant Program, fall 2015.
Who may be able to join
- ≥ 18 years of age
- Employed at Mayo Clinic Rochester as Surgical Assistant, Circulating Nurse, and Scrub Nurse (Surgical Technicians)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Exposure Assessment and Intervention for Reducing Musculoskeletal Stresses and Work-related Injuries Among Allied Health Professionals in Surgical Care
- What are the risk factors that contribute to musculoskeletal injuries and fatigue on allied health professionals in surgical care (e.g. scrub nurses, surgical assistants, and circulating nurses)?
- Can the investigators design wearable devices that the investigators can later evaluate?
- Conditions
- Musculoskeletal Injury, Musculoskeletal Illness
- Keywords
- ergonomic risk factors, allied health professionals, surgical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| risk factors of musculoskeletal injuries | trainees for surgical assistants - determining the level of risk | |
| design wearable devices | Creating feedback mechanism to reduce surgical assistant musculoskeletal risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of awkward postures
Awkward postures will be quantified with motion tracking using an inertial measurement unit (IMU), a lightweight, small sensor. IMU data will be collected and transmitted wirelessly to a real time monitoring system.
Measured: 4 months
Secondary outcomes (1)
Open-ended questionnaire on workflow and usability process to develop automated, unobtrusive, and cost-effective wearable device
Description: Open-ended questionnaire will present participants with the following questions after viewing a presentation on surgical ergonomics and vibrotactile feedback: "Would this device interrupt your work; if so, in what ways," "Are you concerned you may be distracted," Might it interfere with movement in any way," "Could you provide feedback on the vibration settings," etc.time work postures and these data will control tactor activation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Hallbeck, Ph.D., Mayo Clinic
- Investigators
- Susan Hallbeck, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597959
- Sponsor's protocol ID
- 15-002833
- Status last verified
- Sep 2016
- First submitted
- 13 Aug 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure Assessment and Intervention for Reducing Musculoskeletal Stresses and Work-related Injuries Among Allied Health Professionals in Surgical Care
- ClinicalTrials.gov ID
- NCT02597959
- Acronym / sponsor ID
- 15-002833
- Conditions
- Musculoskeletal Injury, Musculoskeletal Illness
- Keywords
- ergonomic risk factors, allied health professionals, surgical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Nov 2015 (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.
- What are the risk factors that contribute to musculoskeletal injuries and fatigue on allied health professionals in surgical care (e.g. scrub nurses, surgical assistants, and circulating nurses)?
- Can the investigators design wearable devices that the investigators can later evaluate?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| risk factors of musculoskeletal injuries | – | –trainees for surgical assistants - determining the level of risk |
| design wearable devices | – | –Creating feedback mechanism to reduce surgical assistant musculoskeletal risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical Assistants, Circulating Nurses, and Scrub Nurses (Surgical Technicians) employed at Mayo Clinic Rochester, MN, are the subjects for Aims 1 and 2. The subject population for the future Aim 3 includes surgical assistant anatomy laboratory students enrolled through the Mayo School of Health Sciences Surgical First Assistant Program, fall 2015.
Key inclusion criteria (2 listed)
- ≥ 18 years of age
- Employed at Mayo Clinic Rochester as Surgical Assistant, Circulating Nurse, and Scrub Nurse (Surgical Technicians)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of awkward postures
Time frame: 4 months
Awkward postures will be quantified with motion tracking using an inertial measurement unit (IMU), a lightweight, small sensor. IMU data will be collected and transmitted wirelessly to a real time monitoring system.
1 secondary outcome
Open-ended questionnaire on workflow and usability process to develop automated, unobtrusive, and cost-effective wearable device
Time frame: 3 months
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 13 Sep 2016.
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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.
Susan Hallbeck, PhD 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?
An observational study of Musculoskeletal Injury and Musculoskeletal Illness, 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 13 Sep 2016. 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?
Frequency of awkward postures (time frame: 4 months). 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 13 Sep 2016.