NCT04141124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

October 23, 2019

Last Update Submit

May 16, 2021

Conditions

Stress, PsychologicalStress, PhysiologicalPerformance AnxietyCritical Incident

Keywords

medical educationsimulated critical situationstress management and performance

Outcome Measures

Primary Outcomes (1)

  • Performance during HFS

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

    day 0: during the HFS

Secondary Outcomes (7)

  • Physiological stress

    day 0: during the HFS

  • Psychological stress

    0: during the HFS

  • Individual psychological characteristics

    0: during the HFS

  • psychological stress consequences

    0: during the HFS

  • Individual psychological characteristics

    0: during the HFS

  • +2 more secondary outcomes

Study Arms (3)

Control

SHAM COMPARATOR

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.

Other: Control

Relaxing Breathing

ACTIVE COMPARATOR

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

Other: Relaxing Breathing

Breathing exercise combined with HRV

EXPERIMENTAL

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

Other: breathing exercise/HRV-biofeedback

Interventions

breathing exercise/HRV-biofeedbackOTHER

5 min of relaxing breathing, coupled with biological feedback.

Also known as: 0
Breathing exercise combined with HRV
Relaxing BreathingOTHER

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

Relaxing Breathing
ControlOTHER

5 minutes of reading fictitious biological medical results

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CLESS

Lyon, Auvergne-Rhône-Alpes, 69007, France

Location

Related Publications (1)

  • 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.

    PMID: 35655176DERIVED

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Marc Lilot, M.D.

    University of Lyon medical center Rockfeller

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Intervention will not be observed by outcomes assessor Performance will be evaluated on video recording after the simulation
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 3 paralel arms of interventions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 28, 2019

Study Start

November 1, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

May 18, 2021

Record last verified: 2021-05

Locations

FR(1)