NCT02597959

Brief Summary

  1. 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. 2.Can the investigators design wearable devices that the investigators can later evaluate?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

August 13, 2015

Last Update Submit

September 12, 2016

Conditions

Musculoskeletal InjuryMusculoskeletal Illness

Keywords

ergonomic risk factorsallied health professionalssurgical care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Open-ended questionnaire on workflow and usability process to develop automated, unobtrusive, and cost-effective wearable device

    3 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • ≥ 18 years of age
  • Employed at Mayo Clinic Rochester as Surgical Assistant, Circulating Nurse, and Scrub Nurse (Surgical Technicians)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Susan Hallbeck, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Consultant II

Study Record Dates

First Submitted

August 13, 2015

First Posted

November 5, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

US(1)