Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05541354 |
| Other study ID # |
5471 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
Fahad Alam, MSc, MD |
| Phone |
416-480-4864 |
| Email |
fahad.alam[@]sunnybrook.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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).
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
1. Assess the perceived and unperceived ergonomic needs of OR teams (surgical,
anesthesiology, and nursing staff and trainees).
2. 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.
