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The Impact of Intraoperative Stretching Microbreaks on Otolaryngologists

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04806308
Recruitment Status : Unknown
Verified March 2021 by Philip Zapanta, George Washington University.
Recruitment status was:  Recruiting
First Posted : March 19, 2021
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Philip Zapanta, George Washington University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Postural; Strain Behavioral: Otolaryngology stretching micro-breaks (OSMB) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Intraoperative Stretching Microbreaks on Otolaryngologists
Estimated Study Start Date : March 16, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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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.
 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.
No Intervention: Control group
Cross over study so each participant will have 3 control days without intervention and 3 intervention days with stretching exercise.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otolaryngologists
  • Currently practicing

Exclusion Criteria:

  • Non-otolarynglogists
  • Currently not practicing
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806308


Contacts
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Contact: Esther Lee, BS 6072204029 estlee@mfa.gwu.edu
Contact: Philip Zapanta, MD (202) 741-3250 pzapanta@mfa.gwu.edu

Locations
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United States, District of Columbia
Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Contact: Esther Lee, BS    607-220-4029    estlee@mfa.gwu.edu   
Principal Investigator: Philip Zapanta, MD         
Sponsors and Collaborators
George Washington University
  Study Documents (Full-Text)

Documents provided by Philip Zapanta, George Washington University:
Study Protocol  [PDF] January 21, 2021

More Information
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Publications of Results:

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Responsible Party: Philip Zapanta, Associate professor, George Washington University
ClinicalTrials.gov Identifier: NCT04806308    
Other Study ID Numbers: ergonomics
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No