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

Primary Purpose

Stress, Psychological, Stress, Physiological, Performance Anxiety

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
breathing exercise/HRV-biofeedback
Relaxing Breathing
Control
Sponsored by
Claude Bernard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress, Psychological focused on measuring medical education, simulated critical situation, stress management and performance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CLESS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Experimental

Arm Label

Control

Relaxing Breathing

Breathing exercise combined with HRV

Arm Description

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.

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

5 minutes of relaxing breathing, guided by a computer helping to follow inspiration and expiration and coupled with direct biological feedback on HRV.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2019
Last Updated
May 16, 2021
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
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1. Study Identification

Unique Protocol Identification Number
NCT04141124
Brief Title
Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During HFS
Acronym
RETROSIMU
Official Title
Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During a High-fidelity Simulation Session.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Stress, Physiological, Performance Anxiety, Critical Incident
Keywords
medical education, simulated critical situation, stress management and performance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 paralel arms of interventions
Masking
InvestigatorOutcomes Assessor
Masking Description
Intervention will not be observed by outcomes assessor Performance will be evaluated on video recording after the simulation
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Relaxing Breathing
Arm Type
Active Comparator
Arm Description
5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration.
Arm Title
Breathing exercise combined with HRV
Arm Type
Experimental
Arm Description
5 minutes of relaxing breathing, guided by a computer helping to follow inspiration and expiration and coupled with direct biological feedback on HRV.
Intervention Type
Other
Intervention Name(s)
breathing exercise/HRV-biofeedback
Other Intervention Name(s)
0
Intervention Description
5 min of relaxing breathing, coupled with biological feedback.
Intervention Type
Other
Intervention Name(s)
Relaxing Breathing
Intervention Description
5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
5 minutes of reading fictitious biological medical results
Primary Outcome Measure Information:
Title
Performance during HFS
Description
Technical specific performance for each scenario. Non-technical performance (with Ottawa GRS Grid).
Time Frame
day 0: during the HFS
Secondary Outcome Measure Information:
Title
Physiological stress
Description
HRV
Time Frame
day 0: during the HFS
Title
Psychological stress
Description
Visual analog scales from 0 to 100 mm the higher the higher stress level
Time Frame
0: during the HFS
Title
Individual psychological characteristics
Description
Personality traits (Big-5)
Time Frame
0: during the HFS
Title
psychological stress consequences
Description
Activation-Desactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness
Time Frame
0: during the HFS
Title
Individual psychological characteristics
Description
Depressive symptoms (Beck) the higher the more depressive symptoms Anxiety-Trait (STAI-T)
Time Frame
0: during the HFS
Title
Individual psychological characteristics
Description
Fear of negative evaluation (PEN). from 0 to 30 the higher the more fear
Time Frame
0: during the HFS
Title
Physiological stress
Description
electrodermal activity
Time Frame
day 0: during the HFS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Lilot, M.D.
Organizational Affiliation
University of Lyon medical center Rockfeller
Official's Role
Principal Investigator
Facility Information:
Facility Name
CLESS
City
Lyon
State/Province
Rhône-Alpes
ZIP/Postal Code
69007
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35655176
Citation
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.
Results Reference
derived

Learn more about this trial

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

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