The Impact of Intraoperative Stretching Microbreaks on Otolaryngologists

March 16, 2021 updated by: Philip Zapanta, George Washington University
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.

Study Overview

Status

Recruiting

Conditions

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

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Recruiting
        • Medical Faculty Associates
        • Contact:
        • Principal Investigator:
          • Philip Zapanta, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Otolaryngologists
  • Currently practicing

Exclusion Criteria:

  • Non-otolarynglogists
  • Currently not practicing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 16, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

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)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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