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

Stress, Psychological Clinical Trial

— RETROSIMU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141124
• Other study ID #: RETROSIMU
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2021
• Source: Claude Bernard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Incident
• Performance Anxiety
• Stress, Physiological
• Stress, Psychological

Intervention

Other:
• breathing exercise/HRV-biofeedback
5 min of relaxing breathing, coupled with biological feedback.
• Relaxing Breathing
5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration.
• Control
5 minutes of reading fictitious biological medical results

Locations

Country	Name	City	State
France	CLESS	Lyon	Rhône-Alpes

Sponsors (10)

Lead Sponsor	Collaborator
Claude Bernard University	Debarnot, U., Claude Bernard University, Duclos, A., Claude Bernard University, Guillot, A., Claude Bernard University, Lehot, J-J., Claude Bernard University, Lilot, M., Claude Bernard University, Louisy, S., Claude Bernard University, Rimmelé, T., Claude Bernard University, Schlatter, S., Claude Bernard University, Therond, C., Claude Bernard University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance during HFS	Technical specific performance for each scenario. Non-technical performance (with Ottawa GRS Grid).	day 0: during the HFS
Secondary	Physiological stress	HRV	day 0: during the HFS
Secondary	Psychological stress	Visual analog scales from 0 to 100 mm the higher the higher stress level	0: during the HFS
Secondary	Individual psychological characteristics	Personality traits (Big-5)	0: during the HFS
Secondary	psychological stress consequences	Activation-Desactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness	0: during the HFS
Secondary	Individual psychological characteristics	Depressive symptoms (Beck) the higher the more depressive symptoms Anxiety-Trait (STAI-T)	0: during the HFS
Secondary	Individual psychological characteristics	Fear of negative evaluation (PEN). from 0 to 30 the higher the more fear	0: during the HFS
Secondary	Physiological stress	electrodermal activity	day 0: during the HFS