Disturbing Factors in the Operating Room

Stress Clinical Trial

Official title:

Disturbing Factors and Stress Levels in Vascular Surgeons During Kidney Transplantations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163537
• Other study ID #: HEEL-2016-01
• Status: Completed
• Phase: N/A
• First received: May 18, 2017
• Last updated: May 29, 2017
• Start date: July 1, 2016
• Est. completion date: May 13, 2017

Study information

• Verified date: May 2017
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 13, 2017
• Est. primary completion date: May 12, 2017
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Disturbing Factors
• Stress

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 hours
Secondary	Stress levels	Stress levels, measured by the HealthPatch	2 hours
Secondary	State Trait Anxiety Inventory	STAI; anxiety questionnaire	5 minutes