Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During HFS (RETROSIMU)

Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During a High-fidelity Simulation Session.

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.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Stress, Physiological; Performance Anxiety; Critical Incident
• Intervention / Treatment: Other: Control; Other: Relaxing Breathing; Other: breathing exercise/HRV-biofeedback

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhône-Alpes
    • Lyon, Rhône-Alpes, France, 69007
      • CLESS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Control; 5 minutes of reading fictitious biological medical results that are almost normal and unrelated to the upcoming scenario. This condition reflects a likely activity in relation to other patients in charge, pending an announced critical situation.	Other: Control; 5 minutes of reading fictitious biological medical results
ACTIVE_COMPARATOR: Relaxing Breathing; 5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration.	Other: Relaxing Breathing; 5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration.
EXPERIMENTAL: Breathing exercise combined with HRV; 5 minutes of relaxing breathing, guided by a computer helping to follow inspiration and expiration and coupled with direct biological feedback on HRV.	Other: breathing exercise/HRV-biofeedback; 5 min of relaxing breathing, coupled with biological feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance during HFS	Technical specific performance for each scenario. Non-technical performance (with Ottawa GRS Grid).	day 0: during the HFS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological stress	HRV	day 0: during the HFS
Psychological stress	Visual analog scales from 0 to 100 mm the higher the higher stress level	0: during the HFS
Individual psychological characteristics	Personality traits (Big-5)	0: during the HFS
psychological stress consequences	Activation-Desactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness	0: during the HFS
Individual psychological characteristics	Depressive symptoms (Beck) the higher the more depressive symptoms Anxiety-Trait (STAI-T)	0: during the HFS
Individual psychological characteristics	Fear of negative evaluation (PEN). from 0 to 30 the higher the more fear	0: during the HFS
Physiological stress	electrodermal activity	day 0: during the HFS

Collaborators and Investigators

• Sponsor: Claude Bernard University
• Collaborators: Schlatter, S., Claude Bernard University; Therond, C., Claude Bernard University; Louisy, S., Claude Bernard University; Duclos, A., Claude Bernard University; Guillot, A., Claude Bernard University; Lehot, J-J., Claude Bernard University; Rimmelé, T., Claude Bernard University; Debarnot, U., Claude Bernard University; Lilot, M., Claude Bernard University
• Investigators: Principal Investigator: Marc Lilot, M.D., University of Lyon medical center Rockfeller

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (ACTUAL): October 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 16, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: medical education; simulated critical situation; stress management and performance
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: RETROSIMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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