- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04806308
The Impact of Intraoperative Stretching Microbreaks on Otolaryngologists
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Esther Lee, BS
- Phone Number: 6072204029
- Email: estlee@mfa.gwu.edu
Study Contact Backup
- Name: Philip Zapanta, MD
- Phone Number: (202) 741-3250
- Email: pzapanta@mfa.gwu.edu
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20037
- Recruiting
- Medical Faculty Associates
-
Contact:
- Esther Lee, BS
- Phone Number: 607-220-4029
- Email: estlee@mfa.gwu.edu
-
Principal Investigator:
- Philip Zapanta, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Otolaryngologists
- Currently practicing
Exclusion Criteria:
- Non-otolarynglogists
- Currently not practicing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Cross over study so each participant will have 3 control days without intervention and 3 intervention days with stretching exercise.
|
Standardized microbreak stretch that is designed to perform intraoperatively within the sterile field at medically convenient 20-40 min intervals throughout each procedure.
|
No Intervention: Control group
Cross over study so each participant will have 3 control days without intervention and 3 intervention days with stretching exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body part discomfort
Time Frame: Given before each surgery during control days as a baseline
|
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
|
Body part discomfort
Time Frame: Given before each surgery during intervention days
|
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
|
Body part discomfort
Time Frame: Given after each surgery during control days as a baseline
|
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
|
Body part discomfort
Time Frame: Given after each surgery during intervention days
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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. doi: 10.1097/SLA.0000000000001665.
- 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 Dec 29.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ergonomics
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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