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Completed

NCT Number: NCT04141124

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

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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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms Critical Incident Performance Anxiety Stress, Physiological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CLESS

Lyon, Auvergne-Rhône-Alpes, 69007, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breathing exercise/HRV-biofeedback

Other

5 min of relaxing breathing, coupled with biological feedback.

Other names: 0

Relaxing Breathing

Other

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

Control

Other

5 minutes of reading fictitious biological medical results

Primary outcomes

  1. Performance during HFS

    Time frame: day 0: during the HFS

    Technical specific performance for each scenario. Non-technical performance (with Ottawa GRS Grid).

Secondary outcomes

  1. Physiological stress

    Time frame: day 0: during the HFS

    HRV

  2. Psychological stress

    Time frame: 0: during the HFS

    Visual analog scales from 0 to 100 mm the higher the higher stress level

  3. Individual psychological characteristics

    Time frame: 0: during the HFS

    Personality traits (Big-5)

  4. psychological stress consequences

    Time frame: 0: during the HFS

    Activation-Desactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness

  5. Individual psychological characteristics

    Time frame: 0: during the HFS

    Depressive symptoms (Beck) the higher the more depressive symptoms Anxiety-Trait (STAI-T)

  6. Individual psychological characteristics

    Time frame: 0: during the HFS

    Fear of negative evaluation (PEN). from 0 to 30 the higher the more fear

  7. Physiological stress

    Time frame: day 0: during the HFS

    electrodermal activity

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Registry information

Official study title

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

Acronym: RETROSIMU

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 28, 2019
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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