WELL-being Improvement Following a SOphrology Intervention in Hospital Staff
So-Well
2 other identifiers
interventional
200
1 country
1
Brief Summary
Work stress and psychosocial risks are a major public health problem. Health-care workers (HCW) are particularly at risk. Moreover, non-HCW staff of hospitals can also be at risk, with working environment described as the main risk factor. The University Hospital (CHU) of Clermont-Ferrand is one of the 3 CHUs in France with more than 10% absenteeism, and the first CHU for duration of sick leave. The political orientations favor an approach to improve the quality of life at work. Sophrology is a psychocorporal method used as a therapeutic technique or experienced as a philosophy of life. It is an exclusively verbal and non-tactile method. It combines a set of techniques that will act both on the body and on the mind through breathing exercises, muscle relaxation and mental imagery (or visualization). It allows to find a state of well-being and to activate all physical and psychological potential in order to acquire a better knowledge of oneself. NLP is a set of communication and self-transformation techniques that focuses on reactions rather than the origins of behaviors. NLP associated with sophrology proposes above all to mobilize the resources of the unconscious. Neurolinguistic programming (NLP) strategies are effective in the improvement in mental (anxiety and depression), physical, and social health, both in the general population, in individuals with social/psychological problems or in patients, both in hospital settings or outside hospital. Similary, sophrology also demonstrated some benefits on symptoms of patients. However, these approaches have never been provided in the workplace for the benefits of workers at risk of stress-related disorders. This protocol may permit improvements of stress-related outcomes. Putative short-term benefits: This protocol may incidentally detect cardiac disorders. Any abnormality discovered will not be covered by promotor's insurance (our exploratory study cannot lead to such event) and will be supported by health insurance. In general, the investigators aim to demonstrate the effectiveness of a workplace sophrology / NLP intervention for HCW at risk of stress-related disorders. Stress and well-being will be the target of the intervention, and will be measured both in a subjective (questionnaire) and objective (biomarkers).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
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
June 13, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedStudy Start
First participant enrolled
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
ExpectedSeptember 22, 2025
November 1, 2024
3 years
June 13, 2022
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
heart rate variability (HRV) Description : Abrupt changes in HRV signals will be explored. Time Frame : During 34 hours in five different conditions
HRV will be explored in time and frequency domains using Zephyr™ BioHarness™ BT.
Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
heart rate variability (HRV) Description : Abrupt changes in HRV signals will be explored. Time Frame : During 34 hours in five different conditions
HRV will be explored in time and frequency domains using Zephyr™ BioHarness™ BT.
Once per month during 6 months
Secondary Outcomes (39)
Skin conductance
Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
Skin conductance
Once per month during 6 months
Demographics variables
Once at inclusion
Clinical measurements (height)
Once at inclusion
Clinical measurements (weight)
Once at inclusion
- +34 more secondary outcomes
Study Arms (2)
intervention group
EXPERIMENTALThe intervention group will have a longitudinal follow-up of seven months in total (a control period of 1 month, then 6 to 8 sophrology sessions during two months, then a 4-month follow-up).
control group
ACTIVE COMPARATORThe control group will have a differed intervention (longitudinal follow-up of seven months in total beginning by a control period without intervention of 3 months, then 6 to 8 sophrology sessions during two months, then a 2-month follow-up).
Interventions
2 sessions will be offered per week at 2 different time and will last 1 hour. They can take place in a seated or standing position, without physical contact. The sessions will consist of breathing exercises, visualization, dynamic relaxation and concentration exercises. The program is standardized: 1. Dialogue between the sophrologist and the participants. It is possible to specify the objective(s) of the session. The sophrologist can ask more specific questions to adapt the session. 2. Presentation of the conduct of the session (possible variations) and instructions promoting autonomy 3. Guided by the sophrologist, the goal is to help free yourself from tensions, to play down a situation that worries and finally to realize that we can deal with. Exercises are adapted to the difficulties encountered by the participants. 4. Time for free expression after the practice to promote the integration of the technique while giving elements to the sophrologist to guide the future sessions.
Eligibility Criteria
You may qualify if:
- worker (HCW or NHCW) from a hospital,
- age between 18-65 years,
- with a stress greater than 50 on a visual analogue scale (VAS) of stress,
- person able to give an informed consent to participate in research and
- affiliated with a Social Security scheme
You may not qualify if:
- Psychiatric, cardiovascular (heart failure, arrhythmia, etc.), hepatic (liver failure, etc.), renal (kidney failure, etc.), or endocrinological diseases (diabetes, etc.) judged by the investigator to be incompatible with the study because they may interfere with the measurements
- Non-affiliated to a health insurance
- Protected persons (minors, pregnant women, breastfeeding women, guardianship, curatorship, deprived of freedoms, safeguard of justice)
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU clermont-ferrand
Clermont-Ferrand, France
Related Publications (1)
Dutheil F, Parreira LM, Pereira B, Baldet M, Marson F, Chabaud C, Blot M, Baker JS, Zak M, Vallet G, Magnon V, Clinchamps M, Altun S. SOphrology Intervention to Improve WELL-Being in Hospital Staff (SO-WELL): Protocol for a Randomized Controlled Trial Study. Int J Environ Res Public Health. 2023 Jan 9;20(2):1185. doi: 10.3390/ijerph20021185.
PMID: 36673939DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric Dutheil
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2022
First Posted
June 21, 2022
Study Start
March 8, 2023
Primary Completion
March 1, 2026
Study Completion (Estimated)
March 1, 2028
Last Updated
September 22, 2025
Record last verified: 2024-11