Impact of Stress and Sleep Management on Emergency Professionals

Healthy Clinical Trial

— REST  

Official title:

Recovery Optimisation in Emergency Medicine Addressing Stress Adaptation Techniques

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05251246
• Other study ID #: 69HCL21_0774
• Secondary ID: 2021-A02218-33
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: February 2023

Study information

• Verified date: February 2022
• Source: Hospices Civils de Lyon
• Contact: Marion DOUPLAT, MD
• Phone: 06 15 34 80 33
• Email: marion.douplat[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: February 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Healthy

Intervention

Behavioral:
• recovery management program
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.

Locations

Country	Name	City	State
France	Hôpital Lyon Sud	Pierre-Bénite

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes post-stressful events
Secondary	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).	2 days (Day22 & Day51)
Secondary	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).	6 days (each shift between Day 15 - Day 21 & Day 44-51)
Secondary	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.	6 days (between Day 15- Day 21 & Day 44-51))
Secondary	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.	7 days (Day 15-Day 21)
Secondary	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	6 days (each shift between Day 15- Day 21 & Day 44-51)
Secondary	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.	6 days (each shift between Day 15- Day 21 & Day 44-51)
Secondary	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	2 days (Day 22 & Day 51)
Secondary	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.	2 days (Day 22 & Day 51)
Secondary	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.	2 days (Day 22 & Day 51)
Secondary	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.	1 day (Day 51)
Secondary	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.	2 days (Day 22 & Day 51)
Secondary	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.	Day 15- Day 21 & Day 44-51