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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stress, Psychological Stress, Physiological Performance Anxiety Critical Incident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 paralel arms of interventions

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Intervention will not be observed by outcomes assessor Performance will be evaluated on video recording after the simulation

Study Groups

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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.

Group Type SHAM_COMPARATOR

Control

Intervention Type OTHER

5 minutes of reading fictitious biological medical results

Relaxing Breathing

5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration.

Group Type ACTIVE_COMPARATOR

Relaxing Breathing

Intervention Type OTHER

5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration.

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.

Group Type EXPERIMENTAL

breathing exercise/HRV-biofeedback

Intervention Type OTHER

5 min of relaxing breathing, coupled with biological feedback.

Interventions

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breathing exercise/HRV-biofeedback

5 min of relaxing breathing, coupled with biological feedback.

Intervention Type OTHER

Relaxing Breathing

5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration.

Intervention Type OTHER

Control

5 minutes of reading fictitious biological medical results

Intervention Type OTHER

Other Intervention Names

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Eligibility Criteria

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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.