- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05974735
Adaptability to Stress of Healthcare Workers in the 8th Arrondissement (ASTRE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75008
- CPTS Paris 8
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- People of legal age
Health professionals and players from the CPTS Paris 8 association:
- Pharmacist,
- Doctor
- Midwife
- Physiotherapist,
- 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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
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
|
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.
|
3 and 6 Months
|
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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
|
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.
|
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
|
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.
|
3 and 6 Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric MYON, CPTS Paris 8
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- PRO-0038
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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