Health BehaviorNCT06295133
Preventive Remediation of Stress for Optimal MEdical StudentS
A study testing Stress in people with Health Behavior and Health-Related Behavior, run by Research on Healthcare Performance Lab U1290 at 1 site in France.
Trial summary
Medical students are subjected to a high competitive pressure throughout their curriculum. High levels of stress are associated with a deterioration in quality of life and learning abilities. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Health-Related Behavior, Stress
- What is being tested?
- Stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024.
- Having read the information note.
- Having signed the written consent.
Who cannot join
- No exclusion criteria will be applied.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
RESHAPE
Lyon, 69008
Sophie Schlatter, Dr., 07 68 21 05 51 ext. 33, sophie.schlatter@univ-lyon1.fr
Angèle Métais, Dr., 06 77 39 89 66 ext. 33, angele.metais@univ-lyon1.fr
About this study
Official title: Determining the Influence of a Stress Management Intervention on Medical Students Levels of Psychophysiological Stress and Satisfaction.
Medical students are subjected to a high competitive pressure throughout their curriculum. High levels of stress are associated with a deterioration in quality of life and learning abilities.
Our field surveys conducted in 2022 and 2023 at the Lyon Est Medical School revealed that second-cycle students presented a high level of stress. It is expected that these feelings significantly degrade their quality of life as well as their health. Furthermore, a local survey reported that one in two medical students had experienced at least one depressive episode, and one in three had already had suicidal thoughts during their curriculum.
Read more
Thus, it would become crucial for medical students to manage stressful situations and reduce stress levels during their studies.
The PROMESS - STRESS project aims to offer solutions to students to reduce their stress levels during their medical studies. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested" and/or "interested" in following a intervention aimed at stress reduction. An early knowledge of stress remediation tools would allow students to quickly acquire the necessary tools to cope with stressful situations they will encounter during their training and their life as future physicians. The objective of this study is to determine the influence of a stress management intervention on medical students levels of psychophysiological stress and satisfaction.
Read the detailed description
Our project aims to support future healthcare professionals to adopt health-promoting behaviors during their studies in a preventive approach. This support will be provided through an intervention of stress management during their curriculum. Specifically, 4th and 5th-year students of the Faculty of Medicine of Lyon Est will have the opportunity to participate in the PROMESS STRESS project. 45 voluntaries will follow a preventive program based on stress management. This intervention will span 11 weeks. At the end of this period, we expect improvements in both subjective and objective indicators of stress.
METHODS.
PRE-INTERVENTION. Week 1. Participants will undergo a two-hour session, during which, they will complete questionnaires on stress. We will also record Heart Rate Variability (HRV).
INTERVENTION. From week 5 to week 11. The stress management intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. Each session includes individual interviews between a stress expert and the participant (i.e. student).
The sessions will be scheduled as follow: week 5 and 6 (session 1), week 7 and 8 (session 2), week 9, 10, and 11 (session 3). During the interview, the expert realizes an initial assessment of student stress levels and gives personalized goals to student. Subsequent sessions follow the same structure.
- Conditions
- Health Behavior, Health-Related Behavior, Stress
- Being tested
- Stress
- Keywords
- Health, Student, Curriculum, Behaviour, Medical, Stress
- Medical subject headings
- Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StressBehavioural
The stress management intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. The sessions will be scheduled as follow: week 5 and 6 (session 1), week 7 and 8 (session 2), week 9, 10, and 11 (session 3). During these sessions, subjective and objective indicators of stress will be recorded to assess the progress of each student.
| Study group | Role | What they receive |
|---|---|---|
| Stress intervention | Experimental | One arm : all volunteers will receive a stress management intervention. Receives: Behavioral: Stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived level of stress : Evolution of the score obtained at the Perceived Stress Scale (PSS).
The students level of stress will be assessed through the PSS questionnaire ranging from 0 (none) to 40 (extreme). One score is assessed and can be classified as low, moderate and elevated stress. The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
Secondary outcomes (25)
Scale of Holmes and Rahe : score obtained at the Holmes and Rahe Questionnaire Inventory.
Quantity of stressors met by the students during the last years. One score is assessed and can be classified as low, medium and high risk of health degradation. This measure will be done during the pre-interventional period at week 1.
Measured: Week 1 (Pre-intervention).
Big-5 : scores obtained at the Big-5 questionnaire.
The students personality traits (i.e. agreeableness, openness, consciousness, extraversion, neuroticism) will be assessed through the questionnaire each score ranges from one to five. This measure will be done during the pre-interventional period at week 1.
Measured: Week 1 (Pre-intervention).
Coping strategies : scores obtained at the Brief Cope Inventory (BCI).
The students coping strategies (social support, active resolution, positive thinking, and avoidance) will be assessed through the BCI questionnaire, each score ranging from 1 to 4; a high score indicating that the behaviour was highly engaged. This measure will be done during the pre-interventional period at week 1.
Measured: Week 1 (Pre-intervention).
Perceived level of stress : score obtained at the Perceived Stress Scale
The students level of stress will be assessed through the PSS questionnaire ranging from 0 (none) to 40 (extreme). One score is assessed and can be classified as low, moderate and elevated stress.This measure will be done during the pre-interventional period at week 1.
Measured: Week 1 (Pre-intervention).
Heart rate variability (HRV) marker: cardiac coherence score during the pre-intervention.
The students basal level of physiological stress will be assessed through the cardiac coherence score, an HRV marker. This measure will be done during the pre-interventional period at week 1.
Measured: Week 1 (Pre-intervention).
Heart rate variability (HRV) marker: SDNN during the pre-intervention.
The students basal level of physiological stress will be assessed through the SDNN score, an HRV marker. SDNN is the standard deviation of the inter-beat-intervals (IBI) measured in ms, NN means "normal" beats, i.e, removing abnormal or false beats. This measure will be done during the pre-interventional period at week 1.
Measured: Week 1 (Pre-intervention).
Heart rate variability (HRV) marker: RMSSD during the pre-intervention.
The students basal level of physiological stress will be assessed through the RMSSD, an HRV marker. RMSSD is the most commonly measured form of HRV, it calculates the difference between successive inter-beat-intervals (IBI) in ms, squares these values and takes the root of the mean.This measure will be done during the pre-interventional period at week 1.
Measured: Week 1 (Pre-intervention).
Heart rate variability (HRV) marker: Low frequency / High frequency ratio (LF/HF) during the pre-intervention.
The students basal level of physiological stress will be assessed through the LF/HF ratio, an HRV marker. HF. The HF band is typically correlated with RMSSD and NN50, lower HF power is associated with stress and anxiety. It is primarily associated with activity in the parasympathetic nervous system.
LF. The LF band is typically associated with the sympathetic nervous system and the HF/LF ratio is often used as a measure of sympathetic-parasympathetic balance in the nervous system.
This measure will be done during the pre-interventional period at week 1.
Measured: Week 1 (Pre-intervention).
Heart rate variability (HRV) marker: pnn50% during the pre-intervention.
The students basal level of physiological stress will be assessed through the pnn50%, an HRV marker. NN50 is the Number of pairs of successive intervals that differ by greater than 50ms. And pNN50 which is more typically used is the proportion of NN50 over all N-N intervals in a sample, expressed as a percentage.This measure will be done during the pre-interventional period at week 1.
Measured: Week 1 (Pre-intervention).
Coping strategies : Evolution in scores obtained at the Brief Cope Inventory (BCI).
The students coping strategies (social support, active resolution, positive thinking, and avoidance) will be assessed through the BCI questionnaire each score will range from 1 to 4; a high score indicating that the behaviour was highly engaged. The measure will be done every session, session 1 (week 5-6) and session 2 (week 7-8), session 2 and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
Heart rate variability (HRV) marker: Evolution in cardiac coherence score during the intervention.
The students level of physiological stress will be assessed through the cardiac coherence, an HRV marker. The measure will be done every session, session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
Heart rate variability (HRV) marker: Evolution in SDNN score during the intervention.
The students level of physiological stress will be assessed through the SDNN, an HRV marker.The measure will be done every session, session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
Heart rate variability (HRV) marker: Evolution in RMSSD score during the intervention.
The students level of physiological stress will be assessed through the RMSSD, an HRV marker.
The measure will be done every session, session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
Heart rate variability (HRV) marker: Evolution in LF/HF ratio during the intervention.
The students level of physiological stress will be assessed through the LF/HF ratio, an HRV marker. The measure will be done every session, session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 25.
Heart rate variability (HRV) marker: Evolution in pnn50% score during the intervention.
The students level of physiological stress will be assessed through the pnn50%, an HRV marker. The measure will be done every session, session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
VAS - stressors quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors
The students quantity of stressors will be assessed on a 100-mm Visual Analogue Scale (VAS: "In the past two weeks, how many stressful situations have you encountered?") ranging from 0 (maximum/extreme) to 100 (zero). The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
VAS - stress quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress.
The students level of stress will be assessed on a 100-mm Visual Analogue Scale (VAS: "In the past two weeks, how would you characterize your stress level?") ranging from 0 (maximum stress) to 100 (no stress at all). The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level.
The emotional valence associated of the students stress level will be assessed on a 100-mm Visual Analogue Scale (VAS: "Over the past two weeks, how would you characterize your stress?") ranging from 0 (very negative feeling) to 100 (very positive feeling).The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
VAS - stress coping: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations.
The students management of stressful situations will be assessed on a 100-mm Visual Analogue Scale (VAS: "Over the past two weeks, how did you manage your stressful situations?") ranging from 0 (very bad stress coping) to 100 (excellent stress coping). The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert.
Following each session, the expert reported if he/she has given during the interview a specific advice according to a pre-established list. For each pre-established advice, he/she has to report if :
- He/she didn't mention this
- He/she mentioned this but didn't directly advise it
- He/she mentioned this and recommended it
- He/she had set this in the goals
- The student was already doing it (positive reinforcement) The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set.
The expert evaluates, from 0 to 3 (i.e. 0 : not achieved at all, 1: slightly achieved, 2: fairly well achieved, 3: well achieved) if he/she estimates that the student has achieve the goals previously set.
The measure will be done at session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention.
The perceived level of the expert satisfaction ("Are you satisfied with the session you just realized?") will be accessed on a likert scale ranging from 1 (not at all satisfied) to 5 (very satisfied). The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5.
The perceived level of expert comfort of the relationship with the student ("How comfortable did you feel with the student?") will be accessed on a likert scale ranging from 1 (not at all comfortable) to 5 (very comfortable). The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
Measured: From week 5 to week 11.
Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress.
The level of expert satisfaction of the student's progress ("Are you satisfied with the student's progress during the all intervention?") will be accessed on a likert scale ranging from 1 (not at all satisfied) to 5 (very satisfied). This measure will be done at the session 3, i.e. approximately at week 9,11,10.
Measured: Week 9-10-11
Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention.
The composite score will be the mean of two sub-scores :
- An intervention specific score : mean of the score obtained at the 100-mm Visual Analogue Scale (VAS: "Do you think the intervention has helped you to decrease your stress level?") ranging from 0 (absolutely not) to 100 (completely) and score obtained at the 100-mm Visual Analogue Scale (VAS :"Do you think the intervention allowed you to better manage the stressful events you encountered?") ranging from 0 (absolutely not) to 100 (completely).
- An intervention general score : mean of the score obtained at the 100-mm Visual Analogue Scale (VAS : "Do you think the proposed goals were suitable for your daily life?") ranging from 0 (absolutely not) to 100 (completely) and the score obtained at the 100-mm Visual Analogue Scale (VAS: "Do you think you can sustain the habit changes?") ranging from 0 (absolutely not) to 100 (completely).
This measure will be done at the session 3, i.e. approximately at week 9,11,10.
Measured: Week 9-10-11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start11 Nov 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All volunteers will receive a stress management intervention.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research on Healthcare Performance Lab U1290
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Schlatter, Dr., Principal investigator, RESHAPE U1290 INSERM UCBL-LYON 1 Rockfeller, Lyon France.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295133
- Sponsor's protocol ID
- PROMESS - STRESS
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Metais A, Omarjee M, Valero B, Gleich A, Mekki A, Henry A, Duclos A, Lilot M, Rode G, Schlatter S. Determining the influence of an intervention of stress management on medical students' levels of psychophysiological stress: the protocol of the PROMESS-Stress clinical trial. BMC Med Educ. 2025 Feb 11;25(1):225. doi: 10.1186/s12909-024-06344-8.
PubMed 39934759
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Influence of a Stress Management Intervention on Medical Students Levels of Psychophysiological Stress and Satisfaction.
- ClinicalTrials.gov ID
- NCT06295133
- Acronym / sponsor ID
- PROMESS - STRESS
- Conditions
- Health Behavior, Health-Related Behavior, Stress
- Keywords
- Health, Student, Curriculum, Behaviour, Medical, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Research on Healthcare Performance Lab U1290University, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medical students are subjected to a high competitive pressure throughout their curriculum. High levels of stress are associated with a deterioration in quality of life and learning abilities.
Our field surveys conducted in 2022 and 2023 at the Lyon Est Medical School revealed that second-cycle students presented a high level of stress. It is expected that these feelings significantly degrade their quality of life as well as their health. Furthermore, a local survey reported that one in two medical students had experienced at least one depressive episode, and one in three had already had suicidal thoughts during their curriculum.
Thus, it would become crucial for medical students to manage stressful situations and reduce stress levels during their studies.
The PROMESS - STRESS project aims to offer solutions to students to reduce their stress levels during their medical studies. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested" and/or "interested" in following a intervention aimed at stress reduction. An early knowledge of stress remediation tools would allow students to quickly acquire the necessary tools to cope with stressful situations they will encounter during their training and their life as future physicians. The objective of this study is to determine the influence of a stress management intervention on medical students levels of psychophysiological stress and satisfaction.
Detailed description
Our project aims to support future healthcare professionals to adopt health-promoting behaviors during their studies in a preventive approach. This support will be provided through an intervention of stress management during their curriculum. Specifically, 4th and 5th-year students of the Faculty of Medicine of Lyon Est will have the opportunity to participate in the PROMESS STRESS project. 45 voluntaries will follow a preventive program based on stress management. This intervention will span 11 weeks. At the end of this period, we expect improvements in both subjective and objective indicators of stress.
METHODS.
PRE-INTERVENTION. Week 1. Participants will undergo a two-hour session, during which, they will complete questionnaires on stress. We will also record Heart Rate Variability (HRV).
INTERVENTION. From week 5 to week 11. The stress management intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. Each session includes individual interviews between a stress expert and the participant (i.e. student).
The sessions will be scheduled as follow: week 5 and 6 (session 1), week 7 and 8 (session 2), week 9, 10, and 11 (session 3). During the interview, the expert realizes an initial assessment of student stress levels and gives personalized goals to student. Subsequent sessions follow the same structure.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All volunteers will receive a stress management intervention.
| Arm | Type | Receives |
|---|---|---|
| Stress intervention | Experimental | Behavioral: StressOne arm : all volunteers will receive a stress management intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024.
- Having read the information note.
- Having signed the written consent.
Key exclusion criteria (1 listed)
- No exclusion criteria will be applied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StressThe stress management intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. The sessions will be scheduled as follow: week 5 and 6 (session 1), week 7 and 8 (session 2), week 9, 10, and 11 (session 3). During these sessions, subjective and objective indicators of stress will be recorded to assess the progress of each student. | Behavioural | Stress intervention |
Primary outcome
Perceived level of stress : Evolution of the score obtained at the Perceived Stress Scale (PSS).
Time frame: From week 5 to week 11.
The students level of stress will be assessed through the PSS questionnaire ranging from 0 (none) to 40 (extreme). One score is assessed and can be classified as low, moderate and elevated stress. The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).
25 secondary outcomes
Scale of Holmes and Rahe : score obtained at the Holmes and Rahe Questionnaire Inventory.
Time frame: Week 1 (Pre-intervention).
Big-5 : scores obtained at the Big-5 questionnaire.
Time frame: Week 1 (Pre-intervention).
Coping strategies : scores obtained at the Brief Cope Inventory (BCI).
Time frame: Week 1 (Pre-intervention).
Perceived level of stress : score obtained at the Perceived Stress Scale
Time frame: Week 1 (Pre-intervention).
Heart rate variability (HRV) marker: cardiac coherence score during the pre-intervention.
Time frame: Week 1 (Pre-intervention).
Heart rate variability (HRV) marker: SDNN during the pre-intervention.
Time frame: Week 1 (Pre-intervention).
Heart rate variability (HRV) marker: RMSSD during the pre-intervention.
Time frame: Week 1 (Pre-intervention).
Heart rate variability (HRV) marker: Low frequency / High frequency ratio (LF/HF) during the pre-intervention.
Time frame: Week 1 (Pre-intervention).
Heart rate variability (HRV) marker: pnn50% during the pre-intervention.
Time frame: Week 1 (Pre-intervention).
Coping strategies : Evolution in scores obtained at the Brief Cope Inventory (BCI).
Time frame: From week 5 to week 11.
Heart rate variability (HRV) marker: Evolution in cardiac coherence score during the intervention.
Time frame: From week 5 to week 11.
Heart rate variability (HRV) marker: Evolution in SDNN score during the intervention.
Time frame: From week 5 to week 11.
Heart rate variability (HRV) marker: Evolution in RMSSD score during the intervention.
Time frame: From week 5 to week 11.
Heart rate variability (HRV) marker: Evolution in LF/HF ratio during the intervention.
Time frame: From week 5 to week 25.
Heart rate variability (HRV) marker: Evolution in pnn50% score during the intervention.
Time frame: From week 5 to week 11.
VAS - stressors quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors
Time frame: From week 5 to week 11.
VAS - stress quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress.
Time frame: From week 5 to week 11.
VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level.
Time frame: From week 5 to week 11.
VAS - stress coping: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations.
Time frame: From week 5 to week 11.
Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert.
Time frame: From week 5 to week 11.
Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set.
Time frame: From week 5 to week 11.
Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention.
Time frame: From week 5 to week 11.
Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5.
Time frame: From week 5 to week 11.
Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress.
Time frame: Week 9-10-11
Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention.
Time frame: Week 9-10-11
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 39934759Metais A, Omarjee M, Valero B, Gleich A, Mekki A, Henry A, Duclos A, Lilot M, Rode G, Schlatter S. Determining the influence of an intervention of stress management on medical students' levels of psychophysiological stress: the protocol of the PROMESS-Stress clinical trial. BMC Med Educ. 2025 Feb 11;25(1):225. doi: 10.1186/s12909-024-06344-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Schlatter, Dr. principal investigator
RESHAPE U1290 INSERM UCBL-LYON 1 Rockfeller, Lyon France.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress in people with Health Behavior and Health-Related Behavior, run by Research on Healthcare Performance Lab U1290 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Schlatter, Dr. (07 68 21 05 51 ext. 33, sophie.schlatter@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived level of stress : Evolution of the score obtained at the Perceived Stress Scale (PSS). (time frame: From week 5 to week 11.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06295133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.