NCT06576570

Brief Summary

The study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. This includes poor positioning and time spent in poor positioning while working in the operating room. The study is also looking to determine if fatigue plays a role in work-related musculoskeletal disorders and whether an education intervention will change ergonomic risk.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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

Study Progress48%
Oct 2024Dec 2027

First Submitted

Initial submission to the registry

August 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

August 21, 2024

Last Update Submit

November 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determine Ergonomic Risk Through Video-based Analysis calculated by an artificial intelligence software and evaluator assessment of Rapid Upper Limb Assessment (RULA) and Rapid Entire Body Assessment (REBA)

    determine the ergonomic risk experienced by surgical attendings and residents during open and laparoscopic surgery measured through video-based analysis of

    1 year

Secondary Outcomes (1)

  • Change in Ergonomic Risk After Reviewing Video Capture and Risk Data

    1 year

Study Arms (1)

Acute Care Surgery Attending and Resident Surgeons

OTHER

Participants will be asked to perform their normal operative work for 5 cases while being filmed. Data will be collected using the SoterTask™ software which calculates momentary data on risk and an aggregate risk level. Two standard ergonomic risk assessments: Rapid Upper Limb Assessment (RULA) or the Rapid Entire Body Assessment (REBA) are also calculated. Both assessments are current best practice standard for determining the level of ergonomic risk. The RULA and REBA data calculated by SoterTask will be compared to scores assessed by the research team from the same video recordings of the work tasks. Following the fifth operative case, participants will view an educational presentation of surgical ergonomics and review the data summarized from the ergonomic measurement system with video of their movement with a visual guideline highlighting high-risk angles and movements including legs, arms, neck and back.

Behavioral: Education presentation of surgical ergonomicsBehavioral: Summary of Ergonomic Measurement System

Interventions

During an individual meeting with participant, a brief presentation will be supplied for review.

Acute Care Surgery Attending and Resident Surgeons

Participant will view a video of their movements with a visual guideline highlighting high-risk angles and movements.

Acute Care Surgery Attending and Resident Surgeons

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any general surgery operative case by a surgeon from the Division of Acute Care Surgery. These cases will be conducted in what has been designated as the "Acute Care Surgery OR" for the day.

You may not qualify if:

  • Any operative case in which the surgical attending or resident has not signed informed consent to record this individual during the case.
  • Any operative case that the surgical attending feels is inappropriate for video recording or when filming could interfere with surgical procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UF Health at Shands Hospital

Gainesville, Florida, 32610, United States

Location

UF Health Shands Hospital at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philip Efron, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Within-subject pre-post design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2024

First Posted

August 28, 2024

Study Start

October 21, 2024

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations