Can a wristband wearable device accurately measure acute stress of novice surgeons during a high-fidelity surgical simulation?
| ISRCTN | ISRCTN10985546 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10985546 |
| Secondary identifying numbers | 7276 |
- Submission date
- 20/02/2018
- Registration date
- 24/02/2018
- Last edited
- 23/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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)
Contact information
Scientific
Medical Physics Laboratory Simulation Center
Athens Medical School
National and Kapodistrian University of Athens
75, Mikras Asias street
Athens
11527
Greece
 ORCID ID |
0000-0003-3615-2500 |
|---|
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available in English. Please use the contact details below to request a patient information sheet in Greek. |
| Scientific title | Feasibility of a new wearable device to estimate acute stress in novices during high-fidelity surgical simulation |
| Study objectives | 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(s) | Athens Medical School Ethics Committee, 19/04/201, ref:1516023954 |
| Health condition(s) or problem(s) studied | 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 | |
| Primary outcome measure | 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 study start date | 01/03/2015 |
| Completion date | 01/03/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 27 |
| Key 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 |
| Key exclusion criteria | if experienced surgeons in simulation |
| Date of first enrolment | 12/12/2016 |
| Date of final enrolment | 20/12/2017 |
Locations
Countries of recruitment
- Greece
Study participating centre
Athens
11527
Greece
Sponsor information
University/education
Medical School
75, Mikras Asias Street
Goudi
11527
Greece
| Phone | +30 210 7462367 |
|---|---|
| medphys@med.uoa.gr | |
"ROR" |
https://ror.org/04gnjpq42 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 03/04/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plans to submit for publication in a high-impact peer reviewed journal. |
| IPD sharing plan | 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 |
