Occupational InjuriesSORENCT05541354
Simulation for Operating Room Ergonomics
An observational study of Occupational Injuries, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Ergonomics is the study of how people interact with, and work within an environment. This idea is especially important in a setting such as the operating room (OR), which can be both physically and mentally challenging. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Occupational Injuries
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 18 Aug 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A purposive sample of OR stakeholders/teams, including surgeons, anesthesiologists, OR nurses and trainees.
Who may be able to join
- Member of an OR team (surgery, anesthesiology or nursing staff or trainee) at Sunnybrook Health Sciences Centre
Who cannot join
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simulation for Operating Room Ergonomics - The SORE Study: Creating an Inter-disciplinary Simulation Curriculum for Operating Room Ergonomics
Ergonomics is the study of how people interact with, and work within an environment. This idea is especially important in a setting such as the operating room (OR), which can be both physically and mentally challenging. Poor ergonomic practices lead to physical discomfort and injuries in >50% of OR staff (surgeons, anesthesiologists, and nurses), impacting OR staff quality of life and leading to staff burnout and early retirement. The end result of which is reduced access to care for patients. Furthermore, the added mental effort of dealing with discomfort and pain can also increase the risk of errors and complications, affecting patient outcomes.
Despite high ergonomic stresses in the OR, and the existence of proven recommendations to address them, only a small number of OR staff are aware of ergonomic solutions and how to apply them. To bridge this gap between knowledge and application, we will assess the ergonomic needs of OR teams and develop an educational simulation curriculum to teach ergonomic recommendations to OR teams (surgery, anesthesiology, and nursing staff and trainees).
Read the detailed description
The Operating Room (OR) is a complex environment with many ergonomic stresses, including those related to patient movement, operative/anesthetic equipment, and surgical bed positioning. Systematic assessments of OR workload have shown that physical demands are at least as high as mental demands for OR teams.
Poor ergonomic management contributes to the high rate of musculoskeletal symptoms (e.g. neck stiffness and back pain) reported by surgeons, OR nurses, and anesthesiologists. These symptoms impact attentional resources and decision-making, increasing the risk of errors and complications. Furthermore, work-related musculoskeletal disorders lead to absenteeism, reduced career longevity, and burnout.
Ergonomic recommendations and interventions for OR staff, including table height adjustments, patient positioning, and placement of equipment, have been developed and proven effective. However, their usefulness is limited by a general lack of awareness and education among OR teams. Despite this, few formalized ergonomic education programs exist.
Furthermore, existing education programs address ergonomics at the individual-level only, and do not consider the interprofessional team environment, potentially limiting effectiveness. Team influence on ergonomics is reliant on non-technical skills such as communication and situational awareness. However, a busy OR environment, where the focus is rightly on patient safety, does not lend itself well to teaching ergonomic principles or providing live feedback. Fortunately, simulation-based training has repeatedly been shown to be an effective teaching tool for such skills. Simulation-based training is also generally positively perceived by medical learners.
With regard to ergonomics specifically, there is emerging evidence that simulation-based teaching can lead to improvements in focused areas of care, such as patient transfer. However, there is currently no simulation curriculum to teach operative ergonomics overall or as a team-based approach. Thus, comprehensive, interprofessional educational programs are needed to increase both awareness and application of ergonomics in the OR. Our study will build an interprofessional, team simulation curriculum involving surgery, anesthesiology, and nursing staff and trainees to address this critical gap in training.
Objectives
- Assess the perceived and unperceived ergonomic needs of OR teams (surgical, anesthesiology, and nursing staff and trainees).
- Develop and pilot an interdisciplinary OR ergonomics simulation curriculum for OR teams.
This exploratory study will take part in 2 Phases.
In Phase I, an interprofessional working group with representatives from surgery, anesthesiology, nursing, physiotherapy, chiropractic, medical education, simulation, and human factors engineering will identify gaps in OR ergonomics to inform the creation of the curriculum. Three strategies will be used to identify problems and assess needs in OR ergonomics: 1) initial literature review; 2) semi-structured stakeholder interviews, 3) direct observation of OR teams performing surgical procedures.
Phase II will involve development and piloting of the educational simulation curriculum with OR teams.
- Conditions
- Occupational Injuries
- Keywords
- Ergonomics, Simulation, Medical Education
- Medical subject headings
- Occupational Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stakeholder Interviews | Semi-structured, open-ended interviews will be conducted via Zoom with a purposive sample of surgeons, anesthesiologists and OR nurses and trainees to identify perceived OR ergonomics issues among stakeholders | |
| OR Observations | Live observation of OR teams by teams of two observers (an anthropologist and an ergonomics expert, such as a chiropractor or physiotherapist). This will be done, in addition to the interview studies, to identify unperceived and misperceived needs using an observation data collection tool. Each of the following 4 phases of surgery will be assessed individually: 1) OR preparation (team arrival to wheels-in), 2) wheels-in to incision, 3) incision to closure, and 4) closure to wheels-out. | |
| Curriculum Piloting | Participating OR teams will take part in piloting sessions of the developed simulation curriculum to determine if it meets the proposed content objectives and ensure environmental validity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of OR ergonomics simulation curriculum
The success of this project will be measured primarily by its development of the final product: an interdisciplinary simulation curriculum for OR ergonomics, with accompanying implementation tools (e.g. website), which is ready to be implemented
Measured: 18-24 months
Secondary outcomes (1)
Ability to obtain peer reviewed funding for effectiveness study
Additional success would be measured by obtaining peer-reviewed funding for a multi-institution implementation and effectiveness assessment of the curriculum.
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start18 Aug 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational InjuriesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541354
- Sponsor's protocol ID
- 5471
- Acronym
- SORE
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation for Operating Room Ergonomics - The SORE Study: Creating an Inter-disciplinary Simulation Curriculum for Operating Room Ergonomics
- ClinicalTrials.gov ID
- NCT05541354
- Acronym / sponsor ID
- SORE / 5471
- Conditions
- Occupational Injuries
- Keywords
- Ergonomics, Simulation, Medical Education
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Sep 2022 (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.
Ergonomics is the study of how people interact with, and work within an environment. This idea is especially important in a setting such as the operating room (OR), which can be both physically and mentally challenging. Poor ergonomic practices lead to physical discomfort and injuries in >50% of OR staff (surgeons, anesthesiologists, and nurses), impacting OR staff quality of life and leading to staff burnout and early retirement. The end result of which is reduced access to care for patients. Furthermore, the added mental effort of dealing with discomfort and pain can also increase the risk of errors and complications, affecting patient outcomes.
Despite high ergonomic stresses in the OR, and the existence of proven recommendations to address them, only a small number of OR staff are aware of ergonomic solutions and how to apply them. To bridge this gap between knowledge and application, we will assess the ergonomic needs of OR teams and develop an educational simulation curriculum to teach ergonomic recommendations to OR teams (surgery, anesthesiology, and nursing staff and trainees).
Detailed description
The Operating Room (OR) is a complex environment with many ergonomic stresses, including those related to patient movement, operative/anesthetic equipment, and surgical bed positioning. Systematic assessments of OR workload have shown that physical demands are at least as high as mental demands for OR teams.
Poor ergonomic management contributes to the high rate of musculoskeletal symptoms (e.g. neck stiffness and back pain) reported by surgeons, OR nurses, and anesthesiologists. These symptoms impact attentional resources and decision-making, increasing the risk of errors and complications. Furthermore, work-related musculoskeletal disorders lead to absenteeism, reduced career longevity, and burnout.
Ergonomic recommendations and interventions for OR staff, including table height adjustments, patient positioning, and placement of equipment, have been developed and proven effective. However, their usefulness is limited by a general lack of awareness and education among OR teams. Despite this, few formalized ergonomic education programs exist.
Furthermore, existing education programs address ergonomics at the individual-level only, and do not consider the interprofessional team environment, potentially limiting effectiveness. Team influence on ergonomics is reliant on non-technical skills such as communication and situational awareness. However, a busy OR environment, where the focus is rightly on patient safety, does not lend itself well to teaching ergonomic principles or providing live feedback. Fortunately, simulation-based training has repeatedly been shown to be an effective teaching tool for such skills. Simulation-based training is also generally positively perceived by medical learners.
With regard to ergonomics specifically, there is emerging evidence that simulation-based teaching can lead to improvements in focused areas of care, such as patient transfer. However, there is currently no simulation curriculum to teach operative ergonomics overall or as a team-based approach. Thus, comprehensive, interprofessional educational programs are needed to increase both awareness and application of ergonomics in the OR. Our study will build an interprofessional, team simulation curriculum involving surgery, anesthesiology, and nursing staff and trainees to address this critical gap in training.
Objectives
- Assess the perceived and unperceived ergonomic needs of OR teams (surgical, anesthesiology, and nursing staff and trainees).
- Develop and pilot an interdisciplinary OR ergonomics simulation curriculum for OR teams.
This exploratory study will take part in 2 Phases.
In Phase I, an interprofessional working group with representatives from surgery, anesthesiology, nursing, physiotherapy, chiropractic, medical education, simulation, and human factors engineering will identify gaps in OR ergonomics to inform the creation of the curriculum. Three strategies will be used to identify problems and assess needs in OR ergonomics: 1) initial literature review; 2) semi-structured stakeholder interviews, 3) direct observation of OR teams performing surgical procedures.
Phase II will involve development and piloting of the educational simulation curriculum with OR teams.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stakeholder Interviews | – | –Semi-structured, open-ended interviews will be conducted via Zoom with a purposive sample of surgeons, anesthesiologists and OR nurses and trainees to identify perceived OR ergonomics issues among stakeholders |
| OR Observations | – | –Live observation of OR teams by teams of two observers (an anthropologist and an ergonomics expert, such as a chiropractor or physiotherapist). This will be done, in addition to the interview studies, to identify unperceived and misperceived needs using an observation data collection tool. Each of the following 4 phases of surgery will be assessed individually: 1) OR preparation (team arrival to wheels-in), 2) wheels-in to incision, 3) incision to closure, and 4) closure to wheels-out. |
| Curriculum Piloting | – | –Participating OR teams will take part in piloting sessions of the developed simulation curriculum to determine if it meets the proposed content objectives and ensure environmental validity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A purposive sample of OR stakeholders/teams, including surgeons, anesthesiologists, OR nurses and trainees.
Key inclusion criteria (1 listed)
- Member of an OR team (surgery, anesthesiology or nursing staff or trainee) at Sunnybrook Health Sciences Centre
Key exclusion criteria (1 listed)
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of OR ergonomics simulation curriculum
Time frame: 18-24 months
The success of this project will be measured primarily by its development of the final product: an interdisciplinary simulation curriculum for OR ergonomics, with accompanying implementation tools (e.g. website), which is ready to be implemented
1 secondary outcome
Ability to obtain peer reviewed funding for effectiveness study
Time frame: 18-24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Injuries, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of OR ergonomics simulation curriculum (time frame: 18-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.