Clinical trial NCT04141124: Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During HFS
Official title: Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During a High-fidelity Simulation Session.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Stress, Physiological
Performance Anxiety
Critical Incident
Keywords: medical education
simulated critical situation
stress management and performance
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
Collaborators: name: Schlatter, S., Claude Bernard University
name: Therond, C., Claude Bernard University
name: Louisy, S., Claude Bernard University
name: Duclos, A., Claude Bernard University
name: Guillot, A., Claude Bernard University
name: Lehot, J-J., Claude Bernard University
name: Rimmelé, T., Claude Bernard University
name: Debarnot, U., Claude Bernard University
name: Lilot, M., Claude Bernard University
First posted: 2019-10-28
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 paralel arms of interventions
Primary purpose: OTHER

Brief summary: The harmful effects of stress on health professionals are expressed both in terms of their health (physical or mental) and the quality of work (reduced memory capacity, deterioration in patient care). These adverse effects highlight the importance of implementing effective coping strategies and/or early learning of stress management methods in medical training programs.

Relaxation breathing techniques coupled with heart rate variability (HRV) biofeedback is one of the new techniques used to reduce the stress level.

No research has yet tested the effects of HRV induced by relaxation breathing technique before managing a simulated critical situation.

Detailed description: This is a randomized, controlled study conducted at the university simulation centre in healthcare of Lyon, France. The high-fidelity simulation (HFS) will be used as a research tool and the topics included will be the HFS residents summoned to critical care situations as part of their training curriculum. The study has received prior approval from the UCBL1. Ethics Committee. After information (protocol and objective of the study), signature of consent, and one minute of relaxing breathing training, the residents as active participants in HFS, will be included in the study. They will be equipped with Hexoskin® jackets collecting heart rate, heart rate variability, breathing rate continuously and an Empathica® connected watch for continuous measurement of electrodermal activity. Then each resident will be randomized into one of the three intervention groups that are:

* a relaxing breathing exercise coupled with biofeedback
* a breathing exercise without biofeedback
* a control occupation (observation of normal biological results). Each intervention will last five minutes and will be conducted between the briefing and the scenario.

Main objective :

The objective of this study is to compare during HFS, the performance of residents during critical care scenarios. The performance analysis will be performed by two independent and blinded evaluators, based on the video recordings of scenarios. The overall performance will be the addition of technical skills (specific rating grid for each scenario on 100 pts) and non-technical skills assessed by the OTTAWA GRS grid (adjusted to 100 pts).

Secondary objectives :

* Compare the effects of the three interventions on reducing psychological stress.
* Compare the effects of the three interventions on reducing physiological stress.
* Compare the effects of the three interventions on increasing cardiac coherence scores.

Eligibility criteria: Inclusion Criteria:

* Adult person
* Registered in specialized diploma of medical training.
* Invited for a high-fidelity simulation session at the Lyon university simulation center.
* Have signed an informed consent form.

Exclusion Criteria:

* pregnant woman

Primary outcomes:
measure: Performance during HFS
timeFrame: day 0: during the HFS
Secondary outcomes:
measure: Physiological stress
timeFrame: day 0: during the HFS
measure: Psychological stress
timeFrame: 0: during the HFS
measure: Individual psychological characteristics
timeFrame: 0: during the HFS
measure: psychological stress consequences
timeFrame: 0: during the HFS
measure: Individual psychological characteristics
timeFrame: 0: during the HFS
measure: Individual psychological characteristics
timeFrame: 0: during the HFS
measure: Physiological stress
timeFrame: day 0: during the HFS
Other outcomes:
Locations:
city: Lyon
country: France
facility: CLESS
state: Rhône-Alpes
Study officials:
affiliation: University of Lyon medical center Rockfeller
name: Marc Lilot, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schlatter ST, Therond CC, Guillot A, Louisy SP, Duclos A, Lehot JJ, Rimmele T, Debarnot US, Lilot ME. Effects of relaxing breathing paired with cardiac biofeedback on performance and relaxation during critical simulated situations: a prospective randomized controlled trial. BMC Med Educ. 2022 Jun 2;22(1):422. doi: 10.1186/s12909-022-03420-9.