Postural; StrainNCT04806308
The Impact of Intraoperative Stretching Microbreaks on Otolaryngologists
A study testing Otolaryngology stretching micro-breaks (OSMB) in people with Postural; Strain, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural; Strain
- What is being tested?
- Otolaryngology stretching micro-breaks (OSMB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Otolaryngologists
- Currently practicing
Who cannot join
- Non-otolarynglogists
- Currently not practicing
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Esther Lee, BS, 607-220-4029, estlee@mfa.gwu.edu
Philip Zapanta, MD
About this study
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.
Read the 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.
- Conditions
- Postural; Strain
- Being tested
- Otolaryngology stretching micro-breaks (OSMB)
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otolaryngology stretching micro-breaks (OSMB)Behavioural
Standardized microbreak stretch that is designed to perform intraoperatively within the sterile field at medically convenient 20-40 min intervals throughout each procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Cross over study so each participant will have 3 control days without intervention and 3 intervention days with stretching exercise. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Given after each surgery during intervention days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start16 Mar 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postural; StrainStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Zapanta, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806308
- Sponsor's protocol ID
- ergonomics
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28059962Hallbeck 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.
PubMed 28166893
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intraoperative Stretching Microbreaks on Otolaryngologists
- ClinicalTrials.gov ID
- NCT04806308
- Acronym / sponsor ID
- ergonomics
- Conditions
- Postural; Strain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 16 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Otolaryngology stretching micro-breaks (OSMB)Cross over study so each participant will have 3 control days without intervention and 3 intervention days with stretching exercise. |
| Control group | No intervention | –Cross over study so each participant will have 3 control days without intervention and 3 intervention days with stretching exercise. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Otolaryngologists
- Currently practicing
Key exclusion criteria (2 listed)
- Non-otolarynglogists
- Currently not practicing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Results publication: PubMed 28059962Park 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.
- Results publication: PubMed 28166893Hallbeck 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.
- Individual participant dataSharing planned: Undecided
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No Disease or Condition is Being Studied
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otolaryngology stretching micro-breaks (OSMB) in people with Postural; Strain, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther Lee, BS (6072204029, estlee@mfa.gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body part discomfort (time frame: Given before each surgery during control days as a baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04806308, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.