Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04141124
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2019-10-23
Brief Title:
Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During HFS
Sponsor:
Claude Bernard University
Organization:
Claude Bernard University
Study Overview
Official Title:
Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During a High-fidelity Simulation Session
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETROSIMU
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 andor 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None