Disturbing FactorsNCT03163537
Disturbing Factors in the Operating Room
An observational study of Disturbing Factors and Stress, run by Radboud University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disturbing Factors, Stress
- What is being tested?
- HealthPatch
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 13 May 2017
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Vascular surgeons during kidney transplantation
Who may be able to join
- All vascular surgeons who are able to perform elective as well as postmoral kidney transplantations
Who cannot join
- -
About this study
Official title: Disturbing Factors and Stress Levels in Vascular Surgeons During Kidney Transplantations
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.
- Conditions
- Disturbing Factors, Stress
- Being tested
- HealthPatch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthPatchDevice
Smart patch that is able to measure stress real time using an algorithm between HR and HRV
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplantation, postmortal, day | Not described Receives: Device: HealthPatch | |
| Kidney transplantation, postmortal, night | Not described Receives: Device: HealthPatch | |
| Kidney transplantation, living donor | Not described Receives: Device: HealthPatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 hours
Secondary outcomes (2)
Stress levels
Stress levels, measured by the HealthPatch
Measured: 2 hours
State Trait Anxiety Inventory
STAI; anxiety questionnaire
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Jul 2016
- Primary completion12 May 2017
- Study completion13 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disturbing FactorsStudies 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
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163537
- Sponsor's protocol ID
- HEEL-2016-01
- Status last verified
- May 2017
- First submitted
- 18 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disturbing Factors and Stress Levels in Vascular Surgeons During Kidney Transplantations
- ClinicalTrials.gov ID
- NCT03163537
- Acronym / sponsor ID
- HEEL-2016-01
- Conditions
- Disturbing Factors, Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 12 May 2017 (actual)
- Study completion
- 13 May 2017 (actual)
- First posted
- 23 May 2017 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kidney transplantation, postmortal, day | – | Device: HealthPatch |
| Kidney transplantation, postmortal, night | – | Device: HealthPatch |
| Kidney transplantation, living donor | – | Device: HealthPatch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Vascular surgeons during kidney transplantation
Key inclusion criteria (1 listed)
- All vascular surgeons who are able to perform elective as well as postmoral kidney transplantations
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| HealthPatchSmart patch that is able to measure stress real time using an algorithm between HR and HRV | Device | Kidney transplantation, living donor, Kidney transplantation, postmortal, day, Kidney transplantation, postmortal, night |
Primary outcome
Factors that are disturbing for vascular surgeons during kidney transplantations
Time frame: 2 hours
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)
2 secondary outcomes
Stress levels
Time frame: 2 hours
State Trait Anxiety Inventory
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Disturbing Factors and Stress, run by Radboud University Medical Center.
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: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Factors that are disturbing for vascular surgeons during kidney transplantations (time frame: 2 hours). 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 31 May 2017; AzTrials last refreshed its copy on 29 Oct 2026.