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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05561283
Other study ID # 69HCL21_1273
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 14, 2022
Est. completion date March 18, 2024

Study information

Verified date May 2024
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Health students are the future actors of the health system. They are exposed to many stressors in their journey. The quality of life of medical students is alarming worldwide: 11.1% of undergraduate and postgraduate residents reportedly have suicidal ideation and 27.2% have depressive symptoms. In addition, 44.2% suffer from burn-out syndrome. In the third cycle, 28.8% suffer from depressive symptoms and 35.1% from burn-out syndrome. This finding is shared internationally among medical residents. Health professionals are facing a global problem which it is crucial to act. At national level, a survey on the mental health of young doctors carried out in 2017 found, among the 7603 residents who responded a prevalence: 22.8% of depressive symptoms, 59.7% of anxiety symptoms, 23.4% of suicidal thoughts, including 5.0% in the month prior to the survey. In 2018, a French report on the quality of life of health by Dr Donata Marra highlighted a real malaise affecting residents and the need to intervene "for residents, for carers and for patients", through the implementation of specific recommendations. The proposal 6 of the report emphasises the prevention of psychosocial risks through educational interventions such as training in collaborative management. On a personal level, the aim is to the leadership of each individual, in terms of stress management, communication, cross-disciplinary skills or even the introduction of relational simulations in the teaching of an awareness of deviant behaviour and harassment. The stress factors are indeed multiple during health studies confrontation with death, competition, increasing responsibilities… Perceived stress has a negative impact on the quality of life and burnout. Effective stress management strategies could therefore help to improve the quality of life of residents. In this context, the analysis of the literature highlights three main areas of intervention that could contribute to resident leadership in favour of their quality of life: stress management, healthy living and the construction of a professional identity. The Junior Leadership programme for residents from the beginning of their professional formation designed to provide basic knowledge and skills in healthcare leadership and to develop cross-disciplinary skills. The aim is to provide the necessary support for the success of the resident's professional project by participating in the improvement of their quality of life and the prevention of psycho-social risks. The study therefore propose to evaluate the feasibility of training in leadership and meditation on the satisfaction of resident.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 18, 2024
Est. primary completion date March 18, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - residents assigned to the Hospices Civils de Lyon - Informed consent given by the resident Exclusion Criteria: - Pregnant women, women in labour or nursing mothers - Persons deprived of their liberty by a judicial or administrative decision - Persons under psychiatric care - Persons of full age who are subject to a legal protection measure (guardianship, curatorship) - Persons who are not affiliated to a social security scheme or who are beneficiaries of a similar scheme

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Self-questionnaires
Self-questionnaires on satisfaction, burn-out, depression, anxiety, relational skills and sleep quality

Locations

Country Name City State
France Pôle de simulation en Santé de Lyon Sud (PL3S) Oullins

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of the satisfaction on the Junior Leadership programme for residents evaluated by the questionnaire recommanded by the HAS The satisfaction of the residents will be evaluated by a self-questionnaire according to model recommended by the Haute Autorité de Santé (HAS)and used in the framework of the SAMSEI programme (SAMSEI="Stratégies d'Apprentissage des Métiers de Santé en Environnement Immersif" that means in English "Learning Strategies for Healthcare Professions in an Immersive Environment") and the Lyon South Health Simulation Centre. The questionnaire will evaluate the interest, practical usefulness, density of information information, conformity with the objectives, the material conditions of the training, the activity of the participants and the motivation to continue the training. At 4 months (at the end of the training that lasts around 4 months)
Secondary Change of proportion of burn-out evaluated the Maslach's burn-out inventory scale The proportion of residents showing symptoms of burn-out will be assessed by the Maslach's burn-out inventory before training and 3 months, 6 months and 1 year after training. Before training (baseline) and 3 months, 6 months and 1 year after training
Secondary Change int he presence of symptoms of anxiety and depression evaluated by the HADS scale Anxiety and depression symptoms will be assessed by Hospital Anxiety and Depression Scale (HADS) before training and at 3 months, 6 months and 1 year after training. Before training (baseline) and 3 months, 6 months and 1 year after training
Secondary Change of the real-life stress levels in the professional environment of residents evaluated by the Karasek scale The stress of residents in their work environment will be assessed using the Karasek scale, which evaluates psychosocial risk factors at work before training and at 3 months, 6 months and and 1 year after the training Before training (baseline) and 3 months, 6 months and 1 year after training
Secondary Change of relational skills evaluated by Cungi and Rey's communication scale Caregivers' interpersonal skills will be assessed by Cungi and Rey's communication scale at 3 months, 6 months and 1 year after the training. Before training (baseline) and 3 months, 6 months and 1 year after training
Secondary Change of sleep quality of the residents evaluated by the LEEDS scale The sleep quality of the residents will be assessed by the LEEDS scale before training and at 3 months, 6 months and 1 year after training Before training (baseline) and 3 months, 6 months and 1 year after training
Secondary Change of the use of psychoactive substances by residents collected by questionnaire The use of psychoactive substances will be collected from residents before the training and at 3 months, 6 months and 1 year after the training Before training (baseline) and 3 months, 6 months and 1 year after training
Secondary Change of the use of medical/psychological by residents collected by questionnaire The use of medical/psychological support will be collected from residents before the training and at 3 months, 6 months and 1 year after the training. Before training (baseline) and 3 months, 6 months and 1 year after training
Secondary Change of the number of days off for sikness collected by questionnaire The number of days off sick will be collected from the residents before the training and at 3 months, 6 months and 1 year after the training. Before training (baseline) and 3 months, 6 months and 1 year after training
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