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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02597959
Other study ID # 15-002833
Secondary ID
Status Completed
Phase N/A
First received August 13, 2015
Last updated September 12, 2016
Start date September 2015
Est. completion date September 2016

Study information

Verified date September 2016
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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?


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- = 18 years of age

- Employed at Mayo Clinic Rochester as Surgical Assistant, Circulating Nurse, and Scrub Nurse (Surgical Technicians)

Exclusion Criteria, Aims 1 and 2:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 months No
Secondary 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. 3 months No
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