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

Not Applicable

Completed

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

• Registration Number: NCT04141124
• Lead Sponsor: Claude Bernard University

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.

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-28
• Study Start: 2019-11-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-16
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
Relaxing Breathing	Relaxing Breathing	5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration.
Breathing exercise combined with HRV	breathing exercise/HRV-biofeedback	5 minutes of relaxing breathing, guided by a computer helping to follow inspiration and expiration and coupled with direct biological feedback on HRV.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Physiological stress	day 0: during the HFS	electrodermal activity
Individual psychological characteristics	0: during the HFS	Fear of negative evaluation (PEN). from 0 to 30 the higher the more fear
psychological stress consequences	0: during the HFS	Activation-Desactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness
Psychological stress	0: during the HFS	Visual analog scales from 0 to 100 mm the higher the higher stress level

Trial Locations

Locations (1)

CLESS; 🇫🇷 Lyon, Rhône-Alpes, France