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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04806308
Other study ID # ergonomics
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 16, 2021
Est. completion date December 31, 2021

Study information

Verified date March 2021
Source George Washington University
Contact Esther Lee, BS
Phone 6072204029
Email estlee@mfa.gwu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There have been numerous survey-based and observational studies reporting a high percentage of otolaryngologists suffering from work-related musculoskeletal symptoms, in which more than half attributed to poor ergonomics in the operating room. Interventions have been implemented in the past to alleviate ergonomic hazards in general surgery such as intra-operative stretch breaks. However, there has not yet been an intervention done to alleviate ergonomic hazards in otolaryngologists. Our study aims to explore the efficacy of implementing intraoperative stretch breaks and assess their effect on otolaryngologists' practices and musculoskeletal pain.


Description:

The study subjects will be recruited voluntarily from George Washington University Hospital otolaryngology attending physicians, residents, and fellows, as well as Children's otolaryngology faculties. Pre-survey will be sent prior to the intervention to obtain background information and baseline ergonomic assessment conducted by physical therapy students. Interventions will include intra-operative stretch breaks that will be implemented by surgeons at their convenient time during the surgery. Post-survey will be sent out to obtain the subjects' experiences after each intervention. Each survey will be sent via email using a secured third-party vendor, RedCap. Results will be retrieved only by the research assistants listed on the institutional review board (IRB). The survey will not ask for any identifying information and will not publish identifying information. The raw data will be analyzed by the PI and research assistant for publication. The study should take less than a year for data collection and analysis.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Otolaryngologists - Currently practicing Exclusion Criteria: - Non-otolarynglogists - Currently not practicing

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Otolaryngology stretching micro-breaks (OSMB)
Standardized microbreak stretch that is designed to perform intraoperatively within the sterile field at medically convenient 20-40 min intervals throughout each procedure.

Locations

Country Name City State
United States Medical Faculty Associates Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hallbeck MS, Lowndes BR, Bingener J, Abdelrahman AM, Yu D, Bartley A, Park AE. The impact of intraoperative microbreaks with exercises on surgeons: A multi-center cohort study. Appl Ergon. 2017 Apr;60:334-341. doi: 10.1016/j.apergo.2016.12.006. Epub 2016 — View Citation

Park AE, Zahiri HR, Hallbeck MS, Augenstein V, Sutton E, Yu D, Lowndes BR, Bingener J. Intraoperative "Micro Breaks" With Targeted Stretching Enhance Surgeon Physical Function and Mental Focus: A Multicenter Cohort Study. Ann Surg. 2017 Feb;265(2):340-346 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Body part discomfort Body Part Discomfort is a validated survey with 0-5 score on the neck, shoulder R/L, hand R/L, lower/upper back, knee R/L, foot R/L. 0 with no pain to 5 with high pain. Given before each surgery during control days as a baseline
Primary Body part discomfort Body Part Discomfort is a validated survey with 0-5 score on the neck, shoulder R/L, hand R/L, lower/upper back, knee R/L, foot R/L. 0 with no pain to 5 with high pain. Given before each surgery during intervention days
Primary Body part discomfort Body Part Discomfort is a validated survey with 0-5 score on the neck, shoulder R/L, hand R/L, lower/upper back, knee R/L, foot R/L. 0 with no pain to 5 with high pain. Given after each surgery during control days as a baseline
Primary Body part discomfort Body Part Discomfort is a validated survey with 0-5 score on the neck, shoulder R/L, hand R/L, lower/upper back, knee R/L, foot R/L. 0 with no pain to 5 with high pain. Given after each surgery during intervention days
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