Impact of Stress and Sleep Management on Emergency Professionals (REST)
Primary Purpose
Healthy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
recovery management program
Sponsored by
About this trial
This is an interventional health services research trial for Healthy focused on measuring sleep deprivation, recovery management program, Stress, Psychological, Stress, Physiological, Emergency Service, Hospital, nurses, physicians
Eligibility Criteria
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
Sites / Locations
- Hôpital Lyon SudRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Without recovery management program
Trained in the recovery management program
Arm Description
Half of the included volunteered participants are randomized in the intervention group
Outcomes
Primary Outcome Measures
Comparison of the recovery capacity for self-reported stressful events after the recovery management program
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.
Secondary Outcome Measures
Evaluation of the perceived stress of the emergency professionals across one week of shift work before and after implementation of the recovery management program.
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).
Evaluation of the perceived stress of the emergency professionals during the shift work before and after implementation of the recovery management program
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).
Evaluation of the psychological markers of stress for self-reported stressful events before and after implementation of the recovery management program.
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.
Comparison of the sleep time and latency of sleep times before and after implementation of the recovery management program.
Sleep time and latency of sleep are recorded by actimetry.
Evaluation of the subjective perception of somnolence before and after implementation of the recovery management program.
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
Evaluation of mental fatigue before and after implementation of the recovery management program
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.
Evaluation of the overall sleepiness before and after implementation of the recovery management program
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
Evaluation of the sleep quality before and after implementation of the recovery management program
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.
Evaluation of bedtime arousal before and after implementation of the recovery management program
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.
Evaluation of the evolution of the perceived quality of sleep before and after implementation of the recovery management program.
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.
Evaluation of the job satisfaction before and after implementation of the recovery management program
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.
Evaluation of the reported adverse events before and after implementation of the recovery management program
Before and after implementation of the recovery, the occurrence of adverse events is measured based on the records.
Full Information
NCT ID
NCT05251246
First Posted
November 30, 2021
Last Updated
February 10, 2022
Sponsor
Hospices Civils de Lyon
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT05251246
Brief Title
Impact of Stress and Sleep Management on Emergency Professionals
Acronym
REST
Official Title
Recovery Optimisation in Emergency Medicine Addressing Stress Adaptation Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
sleep deprivation, recovery management program, Stress, Psychological, Stress, Physiological, Emergency Service, Hospital, nurses, physicians
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Without recovery management program
Arm Type
No Intervention
Arm Title
Trained in the recovery management program
Arm Type
Experimental
Arm Description
Half of the included volunteered participants are randomized in the intervention group
Intervention Type
Behavioral
Intervention Name(s)
recovery management program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of the recovery capacity for self-reported stressful events after the recovery management program
Description
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.
Time Frame
30 minutes post-stressful events
Secondary Outcome Measure Information:
Title
Evaluation of the perceived stress of the emergency professionals across one week of shift work before and after implementation of the recovery management program.
Description
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).
Time Frame
2 days (Day22 & Day51)
Title
Evaluation of the perceived stress of the emergency professionals during the shift work before and after implementation of the recovery management program
Description
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).
Time Frame
6 days (each shift between Day 15 - Day 21 & Day 44-51)
Title
Evaluation of the psychological markers of stress for self-reported stressful events before and after implementation of the recovery management program.
Description
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.
Time Frame
6 days (between Day 15- Day 21 & Day 44-51))
Title
Comparison of the sleep time and latency of sleep times before and after implementation of the recovery management program.
Description
Sleep time and latency of sleep are recorded by actimetry.
Time Frame
7 days (Day 15-Day 21)
Title
Evaluation of the subjective perception of somnolence before and after implementation of the recovery management program.
Description
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
Time Frame
6 days (each shift between Day 15- Day 21 & Day 44-51)
Title
Evaluation of mental fatigue before and after implementation of the recovery management program
Description
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.
Time Frame
6 days (each shift between Day 15- Day 21 & Day 44-51)
Title
Evaluation of the overall sleepiness before and after implementation of the recovery management program
Description
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
Time Frame
2 days (Day 22 & Day 51)
Title
Evaluation of the sleep quality before and after implementation of the recovery management program
Description
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.
Time Frame
2 days (Day 22 & Day 51)
Title
Evaluation of bedtime arousal before and after implementation of the recovery management program
Description
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.
Time Frame
2 days (Day 22 & Day 51)
Title
Evaluation of the evolution of the perceived quality of sleep before and after implementation of the recovery management program.
Description
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.
Time Frame
1 day (Day 51)
Title
Evaluation of the job satisfaction before and after implementation of the recovery management program
Description
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.
Time Frame
2 days (Day 22 & Day 51)
Title
Evaluation of the reported adverse events before and after implementation of the recovery management program
Description
Before and after implementation of the recovery, the occurrence of adverse events is measured based on the records.
Time Frame
Day 15- Day 21 & Day 44-51
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion DOUPLAT, MD
Phone
06 15 34 80 33
Ext
+33
Email
marion.douplat@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie MAZZA, Prof
Phone
06 15 84 24 78
Ext
+33
Email
stephanie.mazza@univ-lyon1.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion DOUPLAT, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stéphanie MAZZA, Prof
Organizational Affiliation
Laboratoire RESHAPE, Université Lyon 1
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion DOUPLAT, MD
Phone
06 15 34 80 33
Ext
+33
Email
marion.douplat@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Marion DOUPLAT, MD
First Name & Middle Initial & Last Name & Degree
Laurent JACQUIN, MD
12. IPD Sharing Statement
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Impact of Stress and Sleep Management on Emergency Professionals
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