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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05974735
Other study ID # PRO-0038
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 9, 2023
Est. completion date August 2024

Study information

Verified date October 2023
Source CPTS Paris 8
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Wellness trail
Setting up wellness trails based on four distinct themes: Food, Nutrition and Micronutrition Physical activity Sleep Stress and well-being

Locations

Country Name City State
France CPTS Paris 8 Paris

Sponsors (2)

Lead Sponsor Collaborator
CPTS Paris 8 ICUREsearch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 Months
Secondary 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. 6 Months
Secondary 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. 3 and 6 Months
Secondary 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. 3 and 6 Months
Secondary 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. 3 and 6 Months
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