Occupational StressASTRENCT05974735
Adaptability to Stress of Healthcare Workers in the 8th Arrondissement
An observational study of Occupational Stress, run by CPTS Paris 8 at 1 site in France.
Trial summary
Participants will be selected according to their affiliation with the Paris 8 CPTS. They will be asked to complete a series of self-questionnaires to determine their stress levels and lifestyle habits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occupational Stress
- What is being tested?
- Wellness trail
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2023to Aug 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Health professionals and actors affiliated to the Communauté professionnelle territoriale de santé (CPTS) Paris 8.
Who may be able to join
- People of legal age
- Health professionals and players from the CPTS Paris 8 association:
- Pharmacist,
- Doctor
- Midwife
- Physiotherapist,
Show all 17Show fewer
- Dentist,
- Nurse,
- Pharmacy assistant,
- Dietician-nutritionist,
- Speech therapist,
- Chiropodist,
- Adapted physical activity teacher,
- Medical secretary,
- Other health service staff (maintenance, reception, general services and IT staff).
- Persons having given their non-opposition to participate in the study.
- Persons affiliated to a social security scheme or beneficiaries of such a scheme (article L1121-11)
Who cannot join
- People already following a wellness programme.
- People undergoing treatment for stress prescribed by a doctor.
- People on sick leave or long-term leave who are no longer at work and who cannot be included in the study.
- People with a poor understanding of spoken and/or written French.
- Vulnerable persons in accordance with article L1121-6 of the CSP.
- Persons subject to a legal protection measure (guardianship, curatorship) or unable to express their consent/non-opposition in accordance with article L1121-8 of the CSP or under court protection in accordance with article L1122-2 of the CSP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptability to Stress of Healthcare Workers in the 8th Arrondissement - Evaluation of Stress Perceived by Healthcare Professionals and Workers. Real-life Prospective Study.
Participants will be selected according to their affiliation with the Paris 8 CPTS. They will be asked to complete a series of self-questionnaires to determine their stress levels and lifestyle habits. These tests will be used to define a wellness pathway for each participant in order to reduce the stress they feel at work. These wellness pathways are based around 4 distinct themes:
- Diet, nutrition and micronutrition
- Physical activity
- Sleep
- Stress and wellness. Participants will be follow-up at 3 and 6 months by means of self-questionnaires and advice on the programme.
- Conditions
- Occupational Stress
- Being tested
- Wellness trail
- Keywords
- professionals and actors health
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness trailBehavioural
Setting up wellness trails based on four distinct themes:
- Food, Nutrition and Micronutrition
- Physical activity
- Sleep
- Stress and well-being
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the 3-month effectiveness of a well-being programme in improving stress management among healthcare professionals and workers with moderate stress.
Changes in the Perceived Stress Scale (PSS) score at 3 months after the SMS setting up the wellness pathway. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.
Measured: 3 Months
Secondary outcomes (4)
Evaluate the effectiveness of a well-being programme in improving stress management in healthcare professionals and workers with moderate stress at 6 months
Change in the Perceived Stress Scale (PSS) at 6 months from the SMS used to set up the wellness pathway. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.
Measured: 6 Months
Evaluate the effectiveness of a well-being programme in improving the lifestyle habits of healthcare professionals and workers at 3 and 6 months
Evolution of the score obtained in the Lifestyle Questionnaire at 3 and 6 months after the SMS for the implementation of the wellness pathway. The Lifestyle Questionnaireis a score based on the assignment of a score for 4 health risk domains: Stress, Diet, Physical Activity and Sleep. The minimum score is 0 and the maximum score is 100 for each of the 4 items. The lower the score, the more the respondent to the questionnaire has a risk profile.
Measured: 3 and 6 Months
Compare the effectiveness of a well-being programme in improving stress management among healthcare professionals and workers, depending on their job
Changes in the Perceived Stress Scale (PSS) according to the professions of the healthcare professionals. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.
Measured: 3 and 6 Months
Observe the acceptability to healthcare professionals and workers of setting up a well-being programme
The participation rate of the participants will be collected through a series of closed questions with multiple choice answers on the type of course taken and the dates of the follow-ups. The satisfaction rate of the participants' well-being journey will be collected through a closed question with a dichotomous answer of the Yes / No type.
Measured: 3 and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start9 Oct 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational StressStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CPTS Paris 8
- Sponsor type
- University, hospital or other
- Collaborators
- ICUREsearch
- Responsible party
- Sponsor
- Investigators
- Eric MYON, Principal investigator, CPTS Paris 8
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974735
- Sponsor's protocol ID
- PRO-0038
- Acronym
- ASTRE
- Status last verified
- Oct 2023
- First submitted
- 12 Jul 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptability to Stress of Healthcare Workers in the 8th Arrondissement - Evaluation of Stress Perceived by Healthcare Professionals and Workers. Real-life Prospective Study.
- ClinicalTrials.gov ID
- NCT05974735
- Acronym / sponsor ID
- ASTRE / PRO-0038
- Conditions
- Occupational Stress
- Keywords
- professionals and actors health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CPTS Paris 8University, hospital or other
- Collaborators
- ICUREsearch
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 3 Aug 2023 (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.
Participants will be selected according to their affiliation with the Paris 8 CPTS. They will be asked to complete a series of self-questionnaires to determine their stress levels and lifestyle habits. These tests will be used to define a wellness pathway for each participant in order to reduce the stress they feel at work. These wellness pathways are based around 4 distinct themes:
- Diet, nutrition and micronutrition
- Physical activity
- Sleep
- Stress and wellness. Participants will be follow-up at 3 and 6 months by means of self-questionnaires and advice on the programme.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Health professionals and actors affiliated to the Communauté professionnelle territoriale de santé (CPTS) Paris 8.
Key inclusion criteria (17 listed)
- People of legal age
- Health professionals and players from the CPTS Paris 8 association:
- Persons having given their non-opposition to participate in the study.
- Persons affiliated to a social security scheme or beneficiaries of such a scheme (article L1121-11)
Key exclusion criteria (6 listed)
- People already following a wellness programme.
- People undergoing treatment for stress prescribed by a doctor.
- People on sick leave or long-term leave who are no longer at work and who cannot be included in the study.
- People with a poor understanding of spoken and/or written French.
- Vulnerable persons in accordance with article L1121-6 of the CSP.
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 |
|---|---|---|
| Wellness trailSetting up wellness trails based on four distinct themes: * Food, Nutrition and Micronutrition * Physical activity * Sleep * Stress and well-being | Behavioural | – |
Primary outcome
Evaluate the 3-month effectiveness of a well-being programme in improving stress management among healthcare professionals and workers with moderate stress.
Time frame: 3 Months
Changes in the Perceived Stress Scale (PSS) score at 3 months after the SMS setting up the wellness pathway. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.
4 secondary outcomes
Evaluate the effectiveness of a well-being programme in improving stress management in healthcare professionals and workers with moderate stress at 6 months
Time frame: 6 Months
Evaluate the effectiveness of a well-being programme in improving the lifestyle habits of healthcare professionals and workers at 3 and 6 months
Time frame: 3 and 6 Months
Compare the effectiveness of a well-being programme in improving stress management among healthcare professionals and workers, depending on their job
Time frame: 3 and 6 Months
Observe the acceptability to healthcare professionals and workers of setting up a well-being programme
Time frame: 3 and 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- 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.
Eric MYON principal investigator
CPTS Paris 8
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Stress, run by CPTS Paris 8 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 17 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. 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?
Results are not available in the source record.
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?
Evaluate the 3-month effectiveness of a well-being programme in improving stress management among healthcare professionals and workers with moderate stress. (time frame: 3 Months). 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 13 Oct 2023.