NCT04806308

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

March 10, 2021

Last Update Submit

March 16, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

Cross over study so each participant will have 3 control days without intervention and 3 intervention days with stretching exercise.

Interventions

Standardized microbreak stretch that is designed to perform intraoperatively within the sterile field at medically convenient 20-40 min intervals throughout each procedure.

Intervention group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Otolaryngologists
  • Currently practicing

You may not qualify if:

  • Non-otolarynglogists
  • Currently not practicing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Esther Lee, BS

CONTACT

Philip Zapanta, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 19, 2021

Study Start

March 16, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations