Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-26 @ 11:14 AM
Study NCT ID:
NCT02597959
Status:
COMPLETED
Last Update Posted:
2016-09-13
First Post:
2015-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Musculoskeletal Stresses and Work-related Injuries Among Allied Health Professionals in Surgical Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2015-08-13', 'studyFirstSubmitQcDate': '2015-11-03', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of awkward postures', 'timeFrame': '4 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Open-ended questionnaire on workflow and usability process to develop automated, unobtrusive, and cost-effective wearable device', 'timeFrame': '3 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ergonomic risk factors', 'allied health professionals', 'surgical care'], 'conditions': ['Musculoskeletal Injury', 'Musculoskeletal Illness']}, 'descriptionModule': {'briefSummary': '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)?\n2. Can the investigators design wearable devices that the investigators can later evaluate?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* Employed at Mayo Clinic Rochester as Surgical Assistant, Circulating Nurse, and Scrub Nurse (Surgical Technicians)\n\nExclusion Criteria, Aims 1 and 2:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02597959', 'briefTitle': 'Reducing Musculoskeletal Stresses and Work-related Injuries Among Allied Health Professionals in Surgical Care', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Exposure Assessment and Intervention for Reducing Musculoskeletal Stresses and Work-related Injuries Among Allied Health Professionals in Surgical Care', 'orgStudyIdInfo': {'id': '15-002833'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'risk factors of musculoskeletal injuries', 'description': 'trainees for surgical assistants - determining the level of risk'}, {'label': 'design wearable devices', 'description': 'Creating feedback mechanism to reduce surgical assistant musculoskeletal risk'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Susan Hallbeck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Associate Consultant II', 'investigatorFullName': 'Susan Hallbeck, Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}