Disturbing Factors in the Operating Room

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.

Study Overview

• Status: Completed
• Conditions: Stress; Disturbing Factors
• Intervention / Treatment: Device: HealthPatch

• Study Type: Observational
• Enrollment (Actual): 45

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Vascular surgeons during kidney transplantation

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Kidney transplantation, postmortal, day	Device: HealthPatch; Smart patch that is able to measure stress real time using an algorithm between HR and HRV
Kidney transplantation, postmortal, night	Device: HealthPatch; Smart patch that is able to measure stress real time using an algorithm between HR and HRV
Kidney transplantation, living donor	Device: HealthPatch; Smart patch that is able to measure stress real time using an algorithm between HR and HRV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress levels	Stress levels, measured by the HealthPatch	2 hours
State Trait Anxiety Inventory	STAI; anxiety questionnaire	5 minutes

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): May 12, 2017
• Study Completion (ACTUAL): May 13, 2017

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (ACTUAL): May 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 29, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HEEL-2016-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes