- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251246
Impact of Stress and Sleep Management on Emergency Professionals (REST)
Recovery Optimisation in Emergency Medicine Addressing Stress Adaptation Techniques
The investigators hypothesize that a recovery management program could have an impact on emergency nurses and physicians by improving their sleep and reducing their psychological and physiological responses when dealing with stressful situations during their professional practice. The REST study consists in developing a recovery management program for emergency professionals. The following strategies would be proposed :
- sleep management according to their schedules by anticipation and recovery,
- stress management through cardio-feedback techniques (cardiac coherence) also called controlled breathing techniques and mental imagery.
The objectives are to evaluate the impact of this program on the physiological and psychological stress of the emergency professionals during their professional activity, as well as on their sleep. To do so, their respiratory and heart rates, as well as their activity and resting times will be recorded continuously for one week. At the end of each shift, the emergency professionals will report and evaluate the 3 most stressful events.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pierre-Bénite, France
- Hôpital Lyon Sud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Nurses or physicians
- In current position for at least one year
- Full time or minimum three shifts per week
- Location: Emergency Department of the Edouard Herriot Hospital or the South Lyon Hospital
- Free and informed consent
Exclusion Criteria:
- Caregivers on leave during the enrollment period
- Pregnant, parturient or breastfeeding caregivers
- Participation in another study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Without recovery management program
|
|
|
Experimental: Trained in the recovery management program
Half of the included volunteered participants are randomized in the intervention group
|
The recovery management program consists in training the nurses and physicians during a 15-day training course to optimize their recovery abilities : sleep management according to the schedules by anticipation and recovery, and stress management through cardio-feedback techniques (cardiac coherence) also called controlled breathing techniques and mental imagery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of the recovery capacity for self-reported stressful events after the recovery management program
Time Frame: 30 minutes post-stressful events
|
During the 30 minutes following self-reported stressful events, the physiological responses to stress (heart rate) are compared between the trained and non-trained emergency professionals.
|
30 minutes post-stressful events
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the perceived stress of the emergency professionals across one week of shift work before and after implementation of the recovery management program.
Time Frame: 2 days (Day22 & Day51)
|
After each monitored week of shift work, the overall perceived stress is collected once using the Perceived Stress Scale (PSS ranging from 0 minimum to 42 maximum).
|
2 days (Day22 & Day51)
|
|
Evaluation of the perceived stress of the emergency professionals during the shift work before and after implementation of the recovery management program
Time Frame: 6 days (each shift between Day 15 - Day 21 & Day 44-51)
|
Before (baseline) and after each shift, the perceived stress during the experienced shift is collected every time using the Visual Analogue Scale VAS for stress intensity (VAS-Stress ranging from 0 minimum to 10 maximum).
|
6 days (each shift between Day 15 - Day 21 & Day 44-51)
|
|
Evaluation of the psychological markers of stress for self-reported stressful events before and after implementation of the recovery management program.
Time Frame: 6 days (between Day 15- Day 21 & Day 44-51))
|
After the shift following self-reported stressful events, the psychological markers of stress are evaluated using the visual analogue scale (VAS-event ranging from 0 minimum to 10 maximum) to indicate the intensity of each event.
|
6 days (between Day 15- Day 21 & Day 44-51))
|
|
Comparison of the sleep time and latency of sleep times before and after implementation of the recovery management program.
Time Frame: 7 days (Day 15-Day 21)
|
Sleep time and latency of sleep are recorded by actimetry.
|
7 days (Day 15-Day 21)
|
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Evaluation of the subjective perception of somnolence before and after implementation of the recovery management program.
Time Frame: 6 days (each shift between Day 15- Day 21 & Day 44-51)
|
During the week of shift observation, before and after the working time, the subjective perception of somnolence is measured using the Karolinska scale (KSS ranging from 0 minimum to 9 maximum) to evaluate the impact of the recovery management program
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6 days (each shift between Day 15- Day 21 & Day 44-51)
|
|
Evaluation of mental fatigue before and after implementation of the recovery management program
Time Frame: 6 days (each shift between Day 15- Day 21 & Day 44-51)
|
During the week of shift observation, after work time, the mental fatigue is measured using a Visual Analogue Scale (VAS ranging from 0 minimum to 10 maximum) to evaluate the impact of the recovery management program.
|
6 days (each shift between Day 15- Day 21 & Day 44-51)
|
|
Evaluation of the overall sleepiness before and after implementation of the recovery management program
Time Frame: 2 days (Day 22 & Day 51)
|
After each monitored week of shift work, the overall sleepiness is measured using the Epworth Sleepiness Scale (ESS ranging from 0 minimum to 24 maximum) to evaluate the impact of the recovery management program
|
2 days (Day 22 & Day 51)
|
|
Evaluation of the sleep quality before and after implementation of the recovery management program
Time Frame: 2 days (Day 22 & Day 51)
|
After each monitored week of shift work, the overall sleep quality is measured using the Insomnia Severity Index (ISI ranging from 0 minimum to 28 maximum) to evaluate the impact of the recovery management program.
|
2 days (Day 22 & Day 51)
|
|
Evaluation of bedtime arousal before and after implementation of the recovery management program
Time Frame: 2 days (Day 22 & Day 51)
|
After each monitored week of shift work the sleep quality is measured using the score on the Pre-Sleep Arousal QScale (PSAS ranging from 16 minimum to 80 maximum) to evaluate the impact of the recovery management program.
|
2 days (Day 22 & Day 51)
|
|
Evaluation of the evolution of the perceived quality of sleep before and after implementation of the recovery management program.
Time Frame: 1 day (Day 51)
|
At the end of the study, the evolution of the perceived quality of sleep is measured using the Leeds questionnaire (LSEQ including VAS from 1 to 10) to evaluate the impact of the recovery management program.
|
1 day (Day 51)
|
|
Evaluation of the job satisfaction before and after implementation of the recovery management program
Time Frame: 2 days (Day 22 & Day 51)
|
Before and after implementation of the recovery, the job satisfaction is measured using a visual analogue scale for the effort-reward imbalance marker (ranging from 0 minimum to 10 maximum) to evaluate the impact of the recovery management program.
|
2 days (Day 22 & Day 51)
|
|
Evaluation of the reported adverse events before and after implementation of the recovery management program
Time Frame: Day 15- Day 21 & Day 44-51
|
Before and after implementation of the recovery, the occurrence of adverse events is measured based on the records.
|
Day 15- Day 21 & Day 44-51
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marion DOUPLAT, MD, Hospices Civils de Lyon
- Study Director: Stéphanie MAZZA, Prof, Laboratoire RESHAPE, Université Lyon 1
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL21_0774
- 2021-A02218-33 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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