The Impact of Intraoperative Stretching Microbreaks on Otolaryngologists

Sponsor

George Washington University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04806308

Collaborator

(none)

100

Enrollment

Location

Arms

9.5

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Mar 16, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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.

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

Primary Outcome Measures

Body part discomfort [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.
Body part discomfort [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.
Body part discomfort [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.
Body part discomfort [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

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Otolaryngologists
Currently practicing

Exclusion Criteria:

Non-otolarynglogists
Currently not practicing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Faculty Associates	Washington	District of Columbia	United States	20037

Sponsors and Collaborators

George Washington University

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol - Jan 21, 2021

More Information

Publications

None provided.

Responsible Party:

Philip Zapanta, Associate professor, George Washington University

ClinicalTrials.gov Identifier:

NCT04806308

Other Study ID Numbers:

ergonomics

First Posted:

Mar 19, 2021

Last Update Posted:

Mar 19, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sprains and Strains

Study Results

No Results Posted as of Mar 19, 2021