Stress, PsychologicalRETROSIMUNCT04141124
Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During HFS
A study testing breathing exercise/HRV-biofeedback and Relaxing Breathing in people with Stress, Psychological and Stress, Physiological, run by Claude Bernard University at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Stress, Physiological, Performance Anxiety
- What is being tested?
- breathing exercise/HRV-biofeedback and Relaxing Breathing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During a High-fidelity Simulation Session.
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.
Read the 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.
- Being tested
- breathing exercise/HRV-biofeedback, Relaxing Breathing, Control
- Keywords
- medical education, simulated critical situation, stress management and performance
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exercise/HRV-biofeedbackOther
Also called 0
5 min of relaxing breathing, coupled with biological feedback.
Relaxing BreathingOther
5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration.
ControlOther
5 minutes of reading fictitious biological medical results
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Control |
| Relaxing Breathing | Active comparator | 5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration. Receives: 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. Receives: Other: breathing exercise/HRV-biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance during HFS
Technical specific performance for each scenario. Non-technical performance (with Ottawa GRS Grid).
Measured: day 0: during the HFS
Secondary outcomes (7)
Physiological stress
HRV
Measured: day 0: during the HFS
Psychological stress
Visual analog scales from 0 to 100 mm the higher the higher stress level
Measured: 0: during the HFS
Individual psychological characteristics
Personality traits (Big-5)
Measured: 0: during the HFS
psychological stress consequences
Activation-Desactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness
Measured: 0: during the HFS
Individual psychological characteristics
Depressive symptoms (Beck) the higher the more depressive symptoms Anxiety-Trait (STAI-T)
Measured: 0: during the HFS
Individual psychological characteristics
Fear of negative evaluation (PEN). from 0 to 30 the higher the more fear
Measured: 0: during the HFS
Physiological stress
electrodermal activity
Measured: day 0: during the HFS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Nov 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 paralel arms of interventions
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilot Marc, Claude Bernard University
- Investigators
- Marc Lilot, M.D., Principal investigator, University of Lyon medical center Rockfeller
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141124
- Sponsor's protocol ID
- RETROSIMU
- Acronym
- RETROSIMU
- Status last verified
- May 2021
- First submitted
- 23 Oct 2019
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35655176
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During a High-fidelity Simulation Session.
- ClinicalTrials.gov ID
- NCT04141124
- Acronym / sponsor ID
- RETROSIMU / RETROSIMU
- Keywords
- medical education, simulated critical situation, stress management and performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 paralel arms of interventions
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Control5 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. |
| Relaxing Breathing | Active comparator | Other: Relaxing Breathing5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration. |
| Breathing exercise combined with HRV | Experimental | Other: breathing exercise/HRV-biofeedback5 minutes of relaxing breathing, guided by a computer helping to follow inspiration and expiration and coupled with direct biological feedback on HRV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breathing exercise/HRV-biofeedbackAlso: 05 min of relaxing breathing, coupled with biological feedback. | Other | Breathing exercise combined with HRV |
| Relaxing Breathing5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration. | Other | Relaxing Breathing |
| Control5 minutes of reading fictitious biological medical results | Other | Control |
Primary outcome
Performance during HFS
Time frame: day 0: during the HFS
Technical specific performance for each scenario. Non-technical performance (with Ottawa GRS Grid).
7 secondary outcomes
Physiological stress
Time frame: day 0: during the HFS
Psychological stress
Time frame: 0: during the HFS
Individual psychological characteristics
Time frame: 0: during the HFS
psychological stress consequences
Time frame: 0: during the HFS
Individual psychological characteristics
Time frame: 0: during the HFS
Individual psychological characteristics
Time frame: 0: during the HFS
Physiological stress
Time frame: day 0: during the HFS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 35655176Schlatter 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Lilot, M.D. principal investigator
University of Lyon medical center Rockfeller
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breathing exercise/HRV-biofeedback and Relaxing Breathing in people with Stress, Psychological and Stress, Physiological, run by Claude Bernard University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance during HFS (time frame: day 0: during the HFS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04141124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.