- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06564519
Resident Posture Biofeedback Study
Check Yourself Before You Wreck Yourself: A Wearable Biofeedback Device to Decrease Surgical Resident's Time in a Non-upright Posture and Work-related Musculoskeletal Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to use a commercially-available posture training device for surgical residents that sends biofeedback in the form of a gentle vibration if posture has deviated from the upright (neutral) position for a long period of time. For residents performing minimally-invasive procedures with a laparoscopic approach, our overarching hypothesis is that the time spent in a non-upright position will be less after using the posture biofeedback device compared with before. The study hypothesizes that residents will report fewer complaints related to musculoskeletal pain after wearing the posture training device.
Residents completing general surgery rotations will be recruited and wear a biofeedback device for about four weeks while performing laparoscopic procedures. Posture data from the device and survey data in the form of the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) will be collected and analyzed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Surgical residents with surgical experience of at least one year (Postgraduate year 2-5)
- Completing a one-month rotation at the study sites within the general surgery department during the study period
Exclusion Criteria:
- Clinically diagnosed inflammatory musculoskeletal disorders per self-report
- History of orthopedic surgery in the last six months per self-report
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Residents
This is a single arm study.
All Resident participants will use the posture biofeedback device.
|
Participants will wear a commercially available posture training device for a two-week tracking period and a two-week training period while performing laparoscopic procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time spent in upright vs non-upright position
Time Frame: week 1 to week 4]
|
proportion (percentage) of time (minutes) in the upright position relative to the non-upright position during laparoscopic procedures
|
week 1 to week 4]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Self-reported musculoskeletal pain score
Time Frame: baseline to week 4
|
Complaints related to musculoskeletal pain assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) - measures self-reported musculoskeletal discomfort for all body segments.
1 = low (score 1-2) 2 = moderate (score 3-4) 3 = high (score 5-7) 4 = very high (score 8-10 - higher scores meaning more discomfort
|
baseline to week 4
|
Collaborators and Investigators
Investigators
- Principal Investigator: William Sherrill, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00115419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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