ClinicalTrials.gg
CompletedNCT03163537Updated May 31, 2017

Disturbing Factors in the Operating Room

An observational study in Disturbing Factors and Stress, sponsored by Radboud University Medical Center. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-05-31.

Sponsored by Radboud University Medical Center · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
45
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Observation of disturbing factors in the operating room and comparison between day and night shift. The investigators have chosen to observe kidney transplantations, since this type of operation has the same priority during day and night. Stress levels of surgeons will be measured using the HealthPatch.

02

Conditions studied

  • Disturbing Factors
  • Stress
03

In context

Lead sponsor

Radboud University Medical Center is the lead sponsor of 985 studies on the registry; 136 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Vascular surgeons during kidney transplantation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All vascular surgeons who are able to perform elective as well as postmoral kidney transplantations

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • Kidney transplantation, postmortal, day

    Device: HealthPatch

  • Kidney transplantation, postmortal, night

    Device: HealthPatch

  • Kidney transplantation, living donor

    Device: HealthPatch

Interventions

  • DeviceHealthPatch

    Smart patch that is able to measure stress real time using an algorithm between HR and HRV

06

What researchers measure

Primary outcomes

  1. Factors that are disturbing for vascular surgeons during kidney transplantations

    One investigator will report all factors that potentially disturb the vascular surgeon during kidney transplantation. Nature and severity of the disturbing factors will be reported, such as opening and closing of doors, beepers. For this, the investigators will use an observational tool for assessing surgical flow disruptions (Parker SE, et al. Development and evaluation of an observational tool for assessing surgical flow disruptions and their impact on surgical performance. World J Surg 2010; 34(2): 353-361)

    Time frame: 2 hours

Secondary outcomes

  1. Stress levels

    Stress levels, measured by the HealthPatch

    Time frame: 2 hours

  2. State Trait Anxiety Inventory

    STAI; anxiety questionnaire

    Time frame: 5 minutes

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2016 to primary completion in May 2017, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2017
First posted
May 23, 2017
StartActual
Jul 1, 2016
Primary completionActual
May 12, 2017
CompletionActual
May 13, 2017
Last update
May 31, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03163537
Responsible party
Sponsor
First posted
May 23, 2017
Start date
Jul 1, 2016
Primary completion
May 12, 2017
Completion
May 13, 2017
Last update
May 31, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion