Condition category
Not Applicable
Date applied
20/02/2018
Date assigned
24/02/2018
Last edited
23/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
It is known that acute stress has a direct impact on surgical performance and patient safety as well. As it is rather unfeasible to measure surgeon’s stress in the operating room, surgical simulation has been proposed as the best alternative, since it is establish way of training that is designed to replicate real-life situations replicating stress, prevent biases and provide objective metrics. As there is no gold standard method to measure stress, several subjective and/or objective methods have been proposed. The rationale for the objective methods lies in the fact that acute stress provokes changes. Therefore changes that are looked at are: Heart rhythm changes as measured by heart rate (HR) or heart rate variability (HRV), electrodermal activity (EDA) levels , thermal activity, blood pressure variability (BVP), and saliva stress biomarkers have been suggested as markers. Using a wearable device that simultaneously captures HR/HRV, BVP, and EDA, in order to evaluate the accuracy of these parameters on stress detection, as well as, to compare them against the most widely method used, the Holter derived HRV could be helpful for measuring stress levels. The aim of this study is to assess the feasibility of a new watch-sized device to noninvasively measure stress parameters in novices during a simulation task in a high fidelity simulator as well as to explore the best stress detector among the recorded parameters. This study also aims to detect if HR and HRV derived parameters when calculated from this wearable device can substitute reciprocal Holter measurements in our simulation environment.

Who can participate?
Male medical school trainees aged 23 to 26 years old

What does the study involve?
Participants are introduced to the simulator, briefed of the tasks to follow and given detailed information about the data recording equipment and the video-evaluation of their performance. HTye are given the Empatica E4 wristband (E4WB) in their non-dominant hand to wear. Additionally, all participants wear an Holter ECG rhythm monitoring and electrodes positioned in certain positions. A baseline recording phase of 10 minutes is initiated with the subjects engaged in leisurely reading (BL phase). Immediately after the simulation exercise starts, the participants are trained on a basic skills module for 9 minutes and are videotaped for later visual analysis of any major errors (failures) detection followed by a 6 minutes recovery period.

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
Athens University Medical school

When is the study starting and how long is it expected to run for?
March 2015 to March 2018

Who is funding the study?
National and Kapodistrian University of Athens (Greece)

Who is the main contact?
Mr Konstantinos Georgiou (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Mr Konstantinos Georgiou

ORCID ID

http://orcid.org/0000-0003-3615-2500

Contact details

Medical Physics Laboratory Simulation Center
Athens Medical School
National and Kapodistrian University of Athens
75
Mikras Asias street
Athens
11527
Greece

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7276

Study information

Scientific title

Feasibility of a new wearable device to estimate acute stress in novices during high-fidelity surgical simulation

Acronym

Study hypothesis

1. The first objective of this study is to assess the feasibility of a new watch-sized device to noninvasively measure stress parameters in novices during a simulation task in a high fidelity simulator as well as to explore the best stress detector among the recorded parameters.
2. The second objective is to detect if HR and HRV derived parameters when calculated from this wearable device can substitute reciprocal Holter measurements in our simulation environment. .

Ethics approval

Athens Medical School Ethics Committee, 19/04/201, ref:1516023954

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available in English. Please use the contact details below to request a patient information sheet in Greek.

Condition

Healthy participants

Intervention

Prior to the simulation task, all participants complete a questionnaire regarding age, height, weight, and prior simulation experience. An orientation phase is then implemented (approximately 15 minutes) during which the participants are introduced to the simulator, briefed of the tasks to follow and given detailed information about the data recording equipment and the video-evaluation of their performance. Thereafter they wear the wristband (E4WB) in their non dominant hand. Additionally, all participants wear an ambulatory Holter ECG rhythm monitoring and electrodes were positioned in predetermined thorax positions. Throughout the whole experiment, the subjects wear both the E4WB and the Holter rhythm monitor and an ambient temperature was kept in the simulation room in order to avoid any sweating artifacts.

A baseline recording phase of 10 minutes is initiated with the subjects engaged in leisurely reading (BL phase). Immediately after the simulation exercise started (T phase) where the subjects were trained on a basic skills module (Lap mentor, 3D Systems) for 9 minutes and were videotaped for later visual analysis of any major errors (failures) detection (F) followed by a 6 minutes recovery period (R phase). Each phase was tagged by triggering concomitantly the markers on both devices.

Heart Rate (HR), inter-beat interval duration (IBI), electrodermal activity (EDA), 3-axis hand motion activity (Acc), and skin temperature (ST) data were recorded from the E4WB. Furthermore, HR and heart rate variability (HRV) data were obtained from the Holter device.

Intervention type

Phase

Drug names

Primary outcome measures

Stress is detected using the EDA at baseline and after the stimulation.

Secondary outcome measures

1. Heart Rate (HR) is recorded using the E4WB at baseline and after the stimulation
2. Inter-beat interval duration (IBI) is recorded using the E4WB at baseline and after the stimulation
3. Electrodermal activity (EDA) is recorded using the E4WB at baseline and after the stimulation
4. 3-axis hand motion activity (Acc) is recorded using the E4WB at baseline and after the stimulation
5. Skin temperature (ST) data is recorded from the E4WB at baseline and after the stimulation
6. HR and heart rate variability (HRV) data is recorded from the Holter device at baseline and after the stimulation

Overall trial start date

01/03/2015

Overall trial end date

01/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male novice trainees aged 23 to 26 years old
2. Body mass index (BMI) from 18.5 to 24.9
3. Medical students or PHY1
4. No simulation experience prior

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

27

Participant exclusion criteria

if experienced surgeons in simulation

Recruitment start date

12/12/2016

Recruitment end date

20/12/2017

Locations

Countries of recruitment

Greece

Trial participating centre

Athens University Medical school
MPLSC11527
Athens
11527
Greece

Sponsor information

Organisation

National and Kapodistrian University of Athens, Greece

Sponsor details

Medical School
75
Mikras Asias Street
Goudi
11527
Greece
+30 210 7462367
medphys@med.uoa.gr

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

National and Kapodistrian University of Athens, Greece

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plans to submit for publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Konstantinos Georgiou MD at kongeeorgiou@med.uoa.gr

Intention to publish date

03/04/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes