HealthyRESTNCT05251246
Impact of Stress and Sleep Management on Emergency Professionals
A study testing recovery management program in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- recovery management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2022to 31 Oct 2022
- 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
- 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
Who cannot join
- Caregivers on leave during the enrollment period
- Pregnant, parturient or breastfeeding caregivers
- Participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- recovery management program
- Keywords
- sleep deprivation, recovery management program, Stress, Psychological, Stress, Physiological, Emergency Service, Hospital, nurses, physicians
- Medical subject headings
- Sleep Deprivation, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recovery management programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Without recovery management program | No intervention | Not described |
| Trained in the recovery management program | Experimental | Half of the included volunteered participants are randomized in the intervention group Receives: Behavioral: recovery management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes post-stressful events
Secondary outcomes (12)
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).
Measured: 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
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).
Measured: 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.
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.
Measured: 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.
Sleep time and latency of sleep are recorded by actimetry.
Measured: 7 days (Day 15-Day 21)
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
Measured: 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
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.
Measured: 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
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
Measured: 2 days (Day 22 & Day 51)
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.
Measured: 2 days (Day 22 & Day 51)
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.
Measured: 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.
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.
Measured: 1 day (Day 51)
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.
Measured: 2 days (Day 22 & Day 51)
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.
Measured: Day 15- Day 21 & Day 44-51
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start8 Feb 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion DOUPLAT, MD, Principal investigator, Hospices Civils de LyonStéphanie MAZZA, Prof, Study director, Laboratoire RESHAPE, Université Lyon 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251246
- Sponsor's protocol ID
- 69HCL21_0774
- Other IDs
- 2021-A02218-33
- Acronym
- REST
- Status last verified
- Jul 2025
- First submitted
- 30 Nov 2021
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Optimisation in Emergency Medicine Addressing Stress Adaptation Techniques
- ClinicalTrials.gov ID
- NCT05251246
- Acronym / sponsor ID
- REST / 69HCL21_0774
- Conditions
- Healthy
- Keywords
- sleep deprivation, recovery management program, Stress, Psychological, Stress, Physiological, Emergency Service, Hospital, nurses, physicians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 22 Feb 2022 (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 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without recovery management program | No intervention | – |
| Trained in the recovery management program | Experimental | Behavioral: recovery management programHalf of the included volunteered participants are randomized in the intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Caregivers on leave during the enrollment period
- Pregnant, parturient or breastfeeding caregivers
- Participation in another study
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 |
|---|---|---|
| recovery management programThe 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. | Behavioural | Trained in the recovery management program |
Primary outcome
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.
12 secondary outcomes
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)
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)
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))
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)
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)
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)
Evaluation of the overall sleepiness before and after implementation of the recovery management program
Time frame: 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)
Evaluation of bedtime arousal before and after implementation of the recovery management program
Time frame: 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)
Evaluation of the job satisfaction before and after implementation of the recovery management program
Time frame: 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
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 25 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Marion DOUPLAT, MD principal investigator
Hospices Civils de Lyon
Stéphanie MAZZA, Prof study director
Laboratoire RESHAPE, Université Lyon 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recovery management program in people with Healthy, run by Hospices Civils de Lyon 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 5 inclusion and 3 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 25 Jul 2025. 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. 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?
Comparison of the recovery capacity for self-reported stressful events after the recovery management program (time frame: 30 minutes post-stressful events). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2025.