NCT06331065

Brief Summary

Mental health is a state of well-being in which a person can realize his/her potential, cope with the normal stresses of life, work productively and contribute to his/her community. It refers to a continuum that extends from the promotion of well-being and the prevention of mental disorders to the treatment and rehabilitation of people suffering from these disorders. Healthcare professionals face major mental health challenges, due to the demands of their profession, which is characterized by heavy workloads and confrontation with human distress. The frequency of mental health problems among hospital staff is high, at all stages (malaise, distress, pathologies). A meta-analysis found that caregivers suffer from around 30% anxiety, 30% depression, 30% psychotrauma and 45% sleep disorders. According to the French Labor Code, employers are responsible for the physical and mental health of their employees. The Hospices Civils de Lyon establishment project includes a section on the prevention of psycho-social risks, quality of working life and management. Healthcare professionals, like the general population, have high expectations of non-medication treatments. These non-medication interventions aim to prevent, treat, or cure a health problem. They are non-invasive and non-pharmacological, with certain observable impacts supported by scientific evidence. Mindfulness meditation is one of the most extensively studied non-medication interventions in mental health. Declined in different modalities, its effects focus on improving resilience with efficacy on physical and mental well-being (stress, anxiety, burnout, affect), and their physiological corollary (cardiac and respiratory rhythms), acceptance of reality in stressful situations, reduced interpersonal conflict in emergencies and, more broadly, impact on relational behaviours (anti- and pro-social), teamwork. Managers also benefit, with a strengthening of the aspiration to lead, in a vision fully at the disposal of others. Mindfulness meditation appears to be a practice that promotes mental well-being and could contribute to fulfilment at work. The challenge is to offer a mindfulness meditation program in a hospital department for individual and collective benefit. The main objective is to evaluate the evolution of psychological fulfilment in the workplace of hospital healthcare professionals in a 5-month meditation program between the baseline and the end of the program, in comparison with the evolution over the same period of a control group. The expected outcome is to show that it is possible to implement a mindfulness meditation intervention for hospital staff in care departments, whatever their status or profession, with individual and collective benefits for mental health, psycho-social risks (stress, violence, etc.) and work organization. If it proves to be effective and acceptable, this intervention could be offered more widely within the institution and beyond.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

8 active sites

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

February 21, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

February 21, 2024

Last Update Submit

January 23, 2026

Conditions

Keywords

mindfulnesspreventionpsychological fulfilmentrealistic assessmentoccupational health promotionmental health at workpilot studyhealthcare workers

Outcome Measures

Primary Outcomes (1)

  • Psychological fulfilment at work

    Self-reported psychological fulfilment at work questionnaire for the intervention and control groups. 13-item questionnaire validated in French. Each item is scored 1-7 (1 = strong disagreement; 7 = strongly agree), yielding a total between 13 and 91 (a high score indicating a high level of psychological fulfillment at work).

    Baseline: before the intervention and immediately after the intervention

Secondary Outcomes (18)

  • Psychological fulfilment at work

    3 months immediately after the end of the intervention

  • Mindful state

    Baseline: before the intervention, immediately after the intervention and 3 months immediately after the intervention

  • Aggressiveness

    Baseline: before the intervention, immediately after the intervention and 3 months immediately after the intervention

  • Impulsivity, experience of being disturbed by conflict, and psychological safety.

    Baseline: before the intervention, immediately after the intervention and 3 months immediately after the intervention

  • Occupational stress

    Baseline: before the intervention, immediately after the intervention and 3 months immediately after the intervention

  • +13 more secondary outcomes

Study Arms (2)

Mindfulness meditation practice group

EXPERIMENTAL

Group informed about mindfulness meditation and experimenting with an adapted program based on mindfulness meditation (intervention group).

Other: Information session on mindfulness meditation and questionnairesDevice: Mindfulness meditation experimentation, practice program, questionnaires, individual interview and focus group

Group without mindfulness meditation practice

ACTIVE COMPARATOR

Group informed about mindfulness meditation and without experimentation of mindfulness meditation practice (control group).

Other: Information session on mindfulness meditation and questionnaires

Interventions

The information session on mindfulness meditation is an information meeting on the PROMIND study opened to all hospital professionals from the 8 participating departments, i.e. the intervention and control groups. During this information session, it is specified that it is desirable for the non-intervention groups to maintain their usual practice (or non-practice) during the study, without starting a new practice of mindfulness meditation. Before this meeting, the baseline questionnaires are administered. Immediately after this time, the questionnaire on representations of mindfulness meditation is administered.

Group without mindfulness meditation practiceMindfulness meditation practice group

After randomization, a mindfulness meditation trial session is offered to all professionals in the intervention group follow by the questionnaire on representations of mindfulness meditation administration. Then, interdepartmental focus groups is conducted with leaders. The following mindfulness meditation program consists of 10 1-hour sessions within 15 days, in groups of up to 15 professionals, conducted at the participants' place and time of work, by a certified mindfulness meditation trainer with a recommended daily practice of 10-20 minutes with the possibility of a longer duration, and an audio guidance tool adapted to the study. After the program, and 3 months later, questionnaires are administered for both groups. For the intervention group, individual interviews, and inter-departmental focus groups (leaders) are carried out at the end of the intervention, and intra-departmental focus groups are conducted 3 months after the end.

Mindfulness meditation practice group

Eligibility Criteria

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

You may qualify if:

  • Being a Hospices Civils de Lyon professional working in a department participating in the project
  • Being of legal age
  • Having given written consent including voice recording for focus groups and semi-structured interviews

You may not qualify if:

  • Self-reported neuro-psychiatric pathology with current severe clinical instability
  • Adults under legal protection (guardianship, curators)
  • Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
  • Persons unable to understand or write in French
  • Pregnant and nursing mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Neurology Department, Pierre Wertheimer Hospital (Hospices Civils de Lyon)

Bron, 69677, France

Location

Pediatric Intensive Care Unit - Continuous Monitoring, Femme Mère Enfant Hospital (Hospices Civils de Lyon)

Bron, 69677, France

Location

Department of Geriatrics, Edouard Herriot Hospital (Hospices Civils de Lyon)

Lyon, 69003, France

Location

Neonatology and neonatal intensive care unit, Croix-Rousse Hospital (Hospices Civils de Lyon)

Lyon, 69004, France

Location

Department of Anesthesia and Intensive Care, Edouard Herriot Hospital (Hospices Civils de Lyon)

Lyon, 69437, France

Location

Anaesthesia - Intensive Care and Perioperative Medicine Department, Lyon South Hospital (Hospices Civils de Lyon)

Pierre-Bénite, 69495, France

Location

Department of Physical Medicine and Neurological Rehabilitation, Henry Gabrielle Hospital (Hospices Civils de Lyon)

Saint-Genis-Laval, 69230, France

Location

Department of Geriatrics, Charpennes Hospital (Hospices Civils de Lyon)

Villeurbanne, 69100, France

Location

MeSH Terms

Interventions

Surveys and QuestionnairesFocus Groups

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ludivine NOHALES

    Hospices Civils de Lyon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 26, 2024

Study Start

May 30, 2024

Primary Completion

November 30, 2024

Study Completion

June 30, 2025

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations