Occupational Injuries Clinical Trial
Official title:
The Effect of Large Versus Small Clog Size on Healthcare Professional Emergency Response Time: a Randomized Controlled Trial
Verified date | May 2020 |
Source | VU University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In many hospitals, clogs, usually white, are provided for healthcare workers. In our
hospital, health care professionals from the department of intensive care medicine may be
summoned to an emergency situation on a 24/7 basis. Clogs are thought to be of importance for
running. Although clogs are available in several sizes, clog size is typically left to the
discretion of the individual healthcare worker. Interestingly,
The primary goal of this randomized controlled trial is to assess if wearing large size clogs
as compared to small size clogs results in increased running speed.
Participants will be randomized to small versus large clog size using a using randomly
permuted blocks stratified by gender. Following randomization, participants will wear the
clogs of allocated size and complete a standardized running course.
The primary endpoint is the time taken to complete the course.
The enrolment of 50 subjects would provide 80% power to show a 5-second difference in the
response time at an average response time of 30 seconds with a 6 second standard deviation.
The ethical committee judged the study protocol exempt from extensive review.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 30, 2020 |
Est. primary completion date | March 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthcare workers aged 18 years or older. Exclusion Criteria: - Inability to run on clogs. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC, location VUmc | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
VU University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to complete the running course | The time to complete the course will be compared between the two groups using a linear model with the randomized allocation and the stratification variable as covariates. | Follow-up until 60 minutes. | |
Secondary | Adverse events | Follow-up until 60 minutes. | ||
Secondary | Time to complete the running course for specific subgroups: By gender, job function, level of fitness. | Follow-up until 60 minutes. |
Status | Clinical Trial | Phase | |
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