NCT05561283

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 14, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

September 21, 2022

Last Update Submit

May 6, 2024

Conditions

Keywords

leadershipmeditationresidents

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change of proportion of burn-out evaluated the Maslach's burn-out inventory scale

    Before training (baseline) and 3 months, 6 months and 1 year after training

  • Change int he presence of symptoms of anxiety and depression evaluated by the HADS scale

    Before training (baseline) and 3 months, 6 months and 1 year after training

  • Change of the real-life stress levels in the professional environment of residents evaluated by the Karasek scale

    Before training (baseline) and 3 months, 6 months and 1 year after training

  • Change of relational skills evaluated by Cungi and Rey's communication scale

    Before training (baseline) and 3 months, 6 months and 1 year after training

  • Change of sleep quality of the residents evaluated by the LEEDS scale

    Before training (baseline) and 3 months, 6 months and 1 year after training

  • +3 more secondary outcomes

Study Arms (1)

Cohort of residents

EXPERIMENTAL

Medical residents undergoing the leadership and meditation training

Diagnostic Test: Self-questionnaires

Interventions

Self-questionnairesDIAGNOSTIC_TEST

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

Cohort of residents

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • residents assigned to the Hospices Civils de Lyon
  • Informed consent given by the resident

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pôle de simulation en Santé de Lyon Sud (PL3S)

Oullins, 69921, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 30, 2022

Study Start

November 14, 2022

Primary Completion

March 18, 2024

Study Completion

March 18, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations