Stress, PsychologicalNCT05867238
Impact of Stress Management Training on the Resilience and Stress of Student Nurse Anaesthetists
An observational study of Stress, Psychological, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The study aims to evaluate the effectiveness of stress management training provided to student nurse anaesthetists on: their level of chronic perceived stress in the last month, their level of acute perceived stress each day for one month, their level of resilience and their level of sleep quality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Training stress management
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2023to 15 Sep 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Student nurse anaesthetist from the Grenoble school.
Who may be able to join
- Student nurse anaesthetist
Who cannot join
- Student objecting to the use of their personal information
- Student on study leave.
- Student on sick leave during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to evaluate the effectiveness of stress management training provided to student nurse anaesthetists on: their level of chronic perceived stress in the last month, their level of acute perceived stress each day for one month, their level of resilience and their level of sleep quality.
Read the detailed description
This trial will be conducted at the CHU Grenoble Alpes (CHUGA). Volunteer nurse student anaesthetists trained in stress management will complete questionnaires assessing resilience, perceived stress over the past month, sleep quality and will assess perceived stress on each working day using the visual analogue stress scale over 3 periods of the working day.
The results of the trained students will be compared to the results of the untrained students who participated in the Anaesthesia worker stress in the Operating Room survey registered under the clinical trial number: NCT05392972
The main objective is to evaluate the impact of stress management training provided to nurse anaesthetist students on their chronic perceived stress over one month assessed with the Perceived Stress Scale 10.
The secondary objectives are:
- To compare the level of resilience of students who have received training in stress management methods with that of students who have not received such training. (Comparison of the average of the Connor-Davidson resilience scale for each population)
- Compare the perceived stress during a working day in students who have received stress management training to those who have not. (Comparison of the average of the two visual analogue stress scales (VAS Stress) (start of shift/end of shift) collected on working days over a period of one month for both populations)
- Compare the stress peaks experienced (acute stress) by students who have received stress management training and those experienced by students who have not. (Comparison of the median of the stress VAS peaks of the two populations followed over one month).
- Determine whether the quality of sleep of the students is influenced by the stress management training (comparison of the pittsburgh sleep quality index (PSQI) of the nurse student anaesthesist population that received stress management training with the PSQI of population that did not receive this training).
- Conduct a satisfaction survey among the nurse student anaesthesist regarding the training provided by the Grenoble training institute and identify the stress management methods retained as useful by the nurse student anesthesist following this training.
- Conditions
- Stress, Psychological
- Being tested
- Training stress management
- Keywords
- Resilience, Acute stress, sleep quality, Anaesthetist, chronic stress
- Medical subject headings
- Stress, Psychological, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training stress managementOther
The stress management training included 1 day and a half day. It was given by a therapist trained in transactional analysis and a trainer from the nurse anaesthetist school. The training was based on cognitive behavioural stress management training and the use of stress management exercises: cardiac coherence, mindfulness meditation, muscle relaxation, mental imagery.
| Study group | Role | What they receive |
|---|---|---|
| Student nurse anaesthetists with no training in stress management | Student nurse anaesthetists who participated in the previous study: stress of anaesthesia professionals in the operating theatre and did not receive stress management training. | |
| Student nurse anaesthetists with training in stress management | Volunteer nurse anaesthetist students who have received training in stress management this year. Receives: Other: Training stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale 10
The Perceived Stress Scale (PSS10 from 10 To 50) measures the degree to which respondents feel their lives are unpredictable, uncontrollable, and overloaded. A high score indicates more stress.
Measured: at day 30
Secondary outcomes (9)
Resilience
Measurement of resilience by Connor-Davidson Resilience Scale 10 (CDRISC10 from 0 to 40) in participants. A high score indicates better resilience.
Measured: at Day 0
Self-reported stress at the beginning of the workday.
Stress level self reported by participants on visual analogical scale (VAS from 0 to 100); One end of the scale represents the maximum conceivable symptom strength (i. e., 100%), the other end no symptoms whatsoever (i. e., 0%).
Measured: Each work day at the start of the shift. From day 0 to day 30.
Self-reported stress at the end of the workday.
Stress level self reported by participants on visual analogical scale (VAS from 0 to 100); One end of the scale represents the maximum conceivable symptom strength (i. e., 100%), the other end no symptoms whatsoever (i. e., 0%).
Measured: Every working day at the end of the shift. From day 0 to day 30.
Maximum self-reported stress of the workday.
Stress level self reported by participants on visual analogical scale (VAS from 0 to 100); One end of the scale represents the maximum conceivable symptom strength (i. e., 100%), the other end no symptoms whatsoever (i. e., 0%).
Measured: Every working day at the end of the shift. From day 0 to day 30.
The score of the Pittsburgh Sleep Quality Index (PSQI)
The PSQI contains 19 self-assessed questions. These 19 questions combine to yield 7 components: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbance, (6) use of sleeping medication, and (7) daytime dysfunction. Each component gives a score from 0 to 3 points (0 indicates no difficulty, while 3 indicates major difficulty). The scores of the seven components are then added together to give an overall score of 0 to 21 points (0 indicating no difficulty, and 21 indicating major difficulty).
Measured: at day 30
overall satisfaction with the stress management training received
Scale from 0 to 10 or a higher score indicates a higher level of satisfaction.
Measured: at day 30
Have you implemented any of the stress management methods proposed during the training?
Yes or No (qualitative)
Measured: at day 30
What method of stress management is used?
choice among: cardiac coherence,self-hypnosis,mental imagery (colourful garden),muscle relaxation,automatic thinking (safe place),rational thinking (autogenic training),breathing meditation, other / free response
Measured: at day 30
If you used stress management methods: how frequently?
choice among : Daily,Weekly,Monthly,The day before an exam,During training periods
Measured: at day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start20 Mar 2023
- Primary completion15 Jun 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Picard, Principal investigator, University Hospital, GrenobleYoann Zafiriou, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867238
- Sponsor's protocol ID
- IRB 00010254 - 2023 - 033
- Status last verified
- Dec 2023
- First submitted
- 5 May 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stress Management Training on the Resilience and Stress of Student Nurse Anaesthetists
- ClinicalTrials.gov ID
- NCT05867238
- Acronym / sponsor ID
- IRB 00010254 - 2023 - 033
- Conditions
- Stress, Psychological
- Keywords
- Resilience, Acute stress, sleep quality, Anaesthetist, chronic stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 19 May 2023 (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.
The study aims to evaluate the effectiveness of stress management training provided to student nurse anaesthetists on: their level of chronic perceived stress in the last month, their level of acute perceived stress each day for one month, their level of resilience and their level of sleep quality.
Detailed description
This trial will be conducted at the CHU Grenoble Alpes (CHUGA). Volunteer nurse student anaesthetists trained in stress management will complete questionnaires assessing resilience, perceived stress over the past month, sleep quality and will assess perceived stress on each working day using the visual analogue stress scale over 3 periods of the working day.
The results of the trained students will be compared to the results of the untrained students who participated in the Anaesthesia worker stress in the Operating Room survey registered under the clinical trial number: NCT05392972
The main objective is to evaluate the impact of stress management training provided to nurse anaesthetist students on their chronic perceived stress over one month assessed with the Perceived Stress Scale 10.
The secondary objectives are:
- To compare the level of resilience of students who have received training in stress management methods with that of students who have not received such training. (Comparison of the average of the Connor-Davidson resilience scale for each population)
- Compare the perceived stress during a working day in students who have received stress management training to those who have not. (Comparison of the average of the two visual analogue stress scales (VAS Stress) (start of shift/end of shift) collected on working days over a period of one month for both populations)
- Compare the stress peaks experienced (acute stress) by students who have received stress management training and those experienced by students who have not. (Comparison of the median of the stress VAS peaks of the two populations followed over one month).
- Determine whether the quality of sleep of the students is influenced by the stress management training (comparison of the pittsburgh sleep quality index (PSQI) of the nurse student anaesthesist population that received stress management training with the PSQI of population that did not receive this training).
- Conduct a satisfaction survey among the nurse student anaesthesist regarding the training provided by the Grenoble training institute and identify the stress management methods retained as useful by the nurse student anesthesist following this training.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Student nurse anaesthetists with no training in stress management | – | –Student nurse anaesthetists who participated in the previous study: stress of anaesthesia professionals in the operating theatre and did not receive stress management training. |
| Student nurse anaesthetists with training in stress management | – | Other: Training stress managementVolunteer nurse anaesthetist students who have received training in stress management this year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Student nurse anaesthetist from the Grenoble school.
Key inclusion criteria (1 listed)
- Student nurse anaesthetist
Key exclusion criteria (3 listed)
- Student objecting to the use of their personal information
- Student on study leave.
- Student on sick leave during the study period.
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 |
|---|---|---|
| Training stress managementThe stress management training included 1 day and a half day. It was given by a therapist trained in transactional analysis and a trainer from the nurse anaesthetist school. The training was based on cognitive behavioural stress management training and the use of stress management exercises: cardiac coherence, mindfulness meditation, muscle relaxation, mental imagery. | Other | Student nurse anaesthetists with training in stress management |
Primary outcome
Perceived Stress Scale 10
Time frame: at day 30
The Perceived Stress Scale (PSS10 from 10 To 50) measures the degree to which respondents feel their lives are unpredictable, uncontrollable, and overloaded. A high score indicates more stress.
9 secondary outcomes
Resilience
Time frame: at Day 0
Self-reported stress at the beginning of the workday.
Time frame: Each work day at the start of the shift. From day 0 to day 30.
Self-reported stress at the end of the workday.
Time frame: Every working day at the end of the shift. From day 0 to day 30.
Maximum self-reported stress of the workday.
Time frame: Every working day at the end of the shift. From day 0 to day 30.
The score of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: at day 30
overall satisfaction with the stress management training received
Time frame: at day 30
Have you implemented any of the stress management methods proposed during the training?
Time frame: at day 30
What method of stress management is used?
Time frame: at day 30
If you used stress management methods: how frequently?
Time frame: at day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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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.
Julien Picard principal investigator
University Hospital, Grenoble
Yoann Zafiriou principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Psychological, run by University Hospital, Grenoble 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 5 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale 10 (time frame: at day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.