Real time assessment of patients’ and healthcare professionals’ reactions during educational training sessions using a simplified electroencephalography and an eye tracking device: a feasibility study

ISRCTN ISRCTN12825237
DOI https://doi.org/10.1186/ISRCTN12825237
Secondary identifying numbers #2016-2134
Submission date
26/04/2017
Registration date
16/05/2017
Last edited
09/03/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Tailoring an educational training session to a learner’s reactions in real time leads to a better learning experience. Capturing these reactions is now possible using two devices: a headset allowing a reading of brain activity (simplified electroencephalography (EEG)) and glasses that follow the learner’s gaze (eye tracking device). These devices can provide new insights about the nature of the learner’s reactions (stress, excitement, engagement, focus, interest and relaxation), the moment at which they are experienced and the effect of the different components of the educational training session. However, the feasibility and acceptability of using these devices still need to be assessed in face-to-face and online educational training sessions. The main aim of this study is to assess the acceptability and feasibility of using a simplified EEG (EMOTIV’s EPOC+ ©) and an eye tracking device (Pupil © Headset) to measure patients’ and health professionals’ reactions. The secondary aims are: to obtain information about emotive and cognitive reactions measured by the EEG (stress, excitement, engagement, focus, interest and relaxation), gaze measured by the eye tracking device, and the comfort of wearing these devices; to establish a process to transfer data from these devices to a database and to produce statistics; to compare the data obtained by EEG with visual scales assessing the same reactions.

Who can participate?
Healthcare professionals (nurses working in the coronary care unit and cardiology residents) and patients in the coronary care unit who are either close to being discharged home or have an altered state of consciousness (delirium).

What does the study involve?
The nurses are asked to wear both devices for 30 minutes during an online educational training session. The cardiology residents are asked to wear the EEG device for 60 minutes during a face-to-face educational training session. The patients close to being discharged are asked to wear both devices for 30 minutes during an educational training session. The patients with an altered state of consciousness wear the EEG device for about 10 minutes. The following measurements are taken: the time needed by the research team to set up each device; the number of measurements obtained by each device versus the number expected; the difficulties encountered setting up the devices; the signal quality of the EEG; and the comfort of the participants while wearing the devices. All measurements are taken by the research nurse and recorded in a database except for the measurements related to the comfort of the participants which are measured using a visual scale. The measurements taken by the simplified EEG (stress, excitement, engagement, focus, interest, and relaxation) are continuously and automatically recorded by the device software. These scores are compared with the ones reported by the patient after the training program using visual scales. The participant’s gaze is also measured using the eye tracking device.

What are the possible benefits and risks of participating?
The results of this study may be used to improve educational training sessions for patients and healthcare professionals. No risks are anticipated. No inconvenience is anticipated except for the time needed to participate.

Where is the study run from?
Montreal Heart Institute Research Center (Canada)

When is the study starting and how long is it expected to run for?
September 2016 to March 2018

Who is funding the study?
1. Montreal Heart Institute Foundation (Canada)
2. The funding of Sylvie Cossette’s laboratory (Canada)

Who is the main contact?
Prof. Sylvie Cossette
sylvie.cossette.inf@umontreal.ca

Contact information

Prof Sylvie Cossette
Public

R -2510
Montreal Heart Institute Research Center
5000 Bélanger street
Montreal
H1T 1C8
Canada

ORCiD logoORCID ID 0000-0001-5840-9122
Phone +1 (0)514 376 3330 ext 4012
Email sylvie.cossette.inf@umontreal.ca

Study information

Study designSingle-centre non-randomized pilot study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleAssessment of emotional-cognitive reactions in patients and health professionals volunteers during educational training sessions using a 14-channel electroencephalography and eye tracking: a feasibility study
Study acronymRECORD
Study objectivesNo hypothesis was formulated.

The main aim of this pilot study is to assess the acceptability and feasibility of using a 14-channel electroencephalography (EMOTIV’s EPOC+ ©) and an eye tracking device (Pupil © Headset) to measure patients’ and health professionals’ emotive and cognitive reactions during educational training sessions.

The secondary aims are:
1. To obtain information about the standard deviations of the 6 variables measured by the 14-channel electroencephalography (stress, excitement, engagement, focus, interest, and relaxation), the variable by the eye tracking device (spatial, temporal and frequencies measures of the), and the comfort of participants wearing these devices
2. Establish a process to transfer data from these devices to an Excel database. Produce some preliminary statistics
3. Compare the data obtained on the variables measured by the 14-channel EEG device with visual analog scale assessing the same constructs
Ethics approval(s)Montreal Heart Institute, 23/03/2017, ref: #2016-2134 – RECORD
Health condition(s) or problem(s) studiedCardiologic care
InterventionParticipants will be asked to wear the 14-channel electroencephalography and/or the eye tracking device for about 15 minutes while they realize either a pre-existing online or face-to-face educational training session.

Regarding the feasibility arm of the study, the following variables will be measured:
1. Time needed by the research team to install and calibrate each device
2. Number of measures obtained by each device versus the number expected
2. Difficulties encountered in the installation of the devices
3. Signal quality of the 14-channel electroencephalography

Regarding the acceptability arm of the study, the following variable will be measured:
1. Comfort of the participants while wearing the devices
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure1. Acceptability of using the 14-channel electroencephalography and the eye tracking device, measured by using the visual analogue scale right at the end of the educational training session
2. Feasibility of using the 14-channel electroencephalography and the eye tracking device, measured by recording the following variables during the experiment:
2.1. Time needed by the research team to install and calibrate each device
2.2. Number of measures obtained by each device versus the number expected
2.3. Difficulties encountered in the installation of the devices
2.4. Signal quality of the simplified electroencephalography. Regarding the acceptability arm of the study, the comfort of the participants while wearing the devices will be measured
3. Emotive and cognitive reactions (stress, excitement, engagement, focus, interest, and relaxation): continuously and automatically interpreted by the MyEmotiv software (produced by the EMOTIV EPOC+ © manufacturer) which provides a score between 0 and 100 for each measure; a higher score indicates a more intense reaction. These scores will be compared with the ones reported by the patient right after the training program by using visual scales
Secondary outcome measuresNo secondary outcome measures
Overall study start date22/09/2016
Completion date23/03/2018

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20 participants; 10 healthcare professionals and 10 patients
Key inclusion criteriaAll participants must be aged 18 or over and be able to speak and read French

Patients
1. Non-hospitalised:
1.1. Completing an online educational training session (TAVIE@COEUR)
2. Hospitalised at the coronary care unit and close to be discharged:
2.1. Hospitalized at the coronary care unit
2.2. Identified by the assistant-chief nurse as potentially being discharged in the next 48 hours
2.3. Completing an online educational training session (TAVIE@COEUR)
3. Hospitalised at the coronary care unit and presenting an altered state of consciousness:
3.1. Hospitalized at the coronary care unit
3.2. Identified by the assistant-chief nurse as having score ≥ 5 at the Ramsay Coma Scale OR as having received a delirium diagnostic
3.3. Have a family member available to consent for the patient

Healthcare professionals
1. Residents: Attending a cardiac-related educational training session provided to a group of medical trainees
2. Coronary care unit nurse: Completing an online educational training session (MOTIV@COEUR)
Key exclusion criteriaParticipants will be excluded if they wear an implantable medical device (e.g. pacemaker, defibrillator, mechanical heart) as radio emissions may interfere with appliances, medical equipment, and automated medical dosimetry systems
Date of first enrolment23/03/2017
Date of final enrolment23/03/2018

Locations

Countries of recruitment

  • Canada

Study participating centre

Montreal Heart Institute
5000 Bélanger Street
Montreal
H1T 1C8
Canada

Sponsor information

Montreal Heart Institute Reasearch Center
Research organisation

R-1520
Montreal Heart Institute Research Center
5000 Bélanger
Montreal
H1T 1C8
Canada

Phone +1 (0)514 376 3330
Email louise.longpre@icm-mhi.org
Website http://www.icm-mhi.org/en/index.html
ROR logo "ROR" https://ror.org/03vs03g62

Funders

Funder type

Charity

Montreal Heart Institute Foundation

No information available

The funding of Sylvie Cossette’s laboratory

No information available

Results and Publications

Intention to publish date01/09/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal for Fall 2017
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a non-publically available repository “Centre de recherche de l’Institut de Cardiologie de Montréal”. No weblink is available.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2018 Yes No

Editorial Notes

09/03/2018: Publication reference added.