- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108767
Innovative and Transdisciplinary Observation Program for the Quality of Life of Health Students (POSITIVE)
Scientific context: Students' quality of life reflects the general health of students, in connection with the studies themselves, but also with physical, biological, social, cultural, and psychological determinants. Indeed, students are young adults exposed to a complex period composed of transitions in different spheres of their life: housing, domestic tasks, social learning, lifestyle choices, etc. In addition to this, students in medical and health sciences have to face with stress due to a demanding training and exposure to the hospital world. According to the Haute Autorité de Santé (HAS), health professionals in activity or in training are identified as a "population at risk historically identified."
The studies on stress and psychological disorders, in medical students, are considerably documented on the international level and the incidence of various psychic problems (depressive state, suicidal ideas ...) and behavioural (food behaviours, addictive behaviours ...) has been shown to be predominant in this population. However, no studies have been conducted on aspects like self-esteem, self-efficacy and extracurricular activities. In this sense, it may be interesting to match quality of life of health students in Lyon compared to the results of the other studies carried out in France, and to have a global approach of the factors influencing quality of life, with identification of factors that are potentially harmful, but also beneficial to the global health. This study will also compare the results according to the different health sectors such as medicine, pharmacy, maieutic, odontology, and sciences of rehabilitation.
Research hypothesis: the study hypothesis is that description of the quality of life and, self-efficacy, self-esteem, nutrition, anxiety, physical activity, sleep quality, and addiction parameters in health student will better characterize student's issues in order to propose an appropriate intervention to improve their global health.
The study is an observational, cross sectional and monocentric study conducted among the population of students of the Lyon 1 University in the health science field on a 9 months period.
Study Overview
Status
Conditions
Study Type
Contacts and Locations
Study Locations
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-
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Lyon, France
- University Health Department Lyon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (> 18 years)
- Enrolled in 3rd year of health study (Medicine, pharmacy, Institute of Rehabilitation Sciences and Techniques, odontology, maieutic) at the UCBL
- Participation at the required medical consultation at the college Health Department of UCBL
Exclusion Criteria:
- Lack of comprehension of the French language
- Implementation of protective measures
- Erasmus program
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Health students enrolled in the 3rd year at the University Cla
Health students enrolled in the 3rd year at the University Claude Bernard Lyon 1, aged over 18 years.
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The cross-sectional study will be conducted in all students in health sciences in 3rd year enrolled at the University Claude Bernard Lyon 1 (UCBL) and participating at the required medical consultation at the college Health Department of UCBL, over a period of 9 months. The self-questionnaires will be completed by the students during the mandatory medical preventive visit at the university health center. All dimensions investigated by the questionnaire are usually questioned by the caregivers during the consultation as part of the usual follow-up of students. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Health student's quality of life: WHOQOL BREF questionnaire
Time Frame: Month 9
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The quality of life will be evaluated by the WHOQOL BREF questionnaire (Caria et al, 1995, Baumann et al, 2010) consisting of 26 items exploring physical health (7 items), psychological health (6 items), social relations (3 items), environment (8 items) and the quality of life related to health attesting to the overall satisfaction (2 items).
Subject responses are collected using a Likert scale, scored from 1 to 5, summed and converted to a scale of 0 (poor quality of life) to 100 (good quality of life).
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Month 9
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Julie Haesebaert, MD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Other Study ID Numbers
- 69HCL19_0398
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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