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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05867238
Other study ID # IRB 00010254 - 2023 - 033
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2023
Est. completion date September 15, 2023

Study information

Verified date December 2023
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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: 1. 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) 2. 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) 3. 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). 4. 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). 5. 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date September 15, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Student nurse anaesthetist Exclusion Criteria: - Student objecting to the use of their personal information - Student on study leave. - Student on sick leave during the study period.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Training stress management
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.

Locations

Country Name City State
France University Grenoble Hospital Grenoble

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at day 30
Secondary Resilience Measurement of resilience by Connor-Davidson Resilience Scale 10 (CDRISC10 from 0 to 40) in participants. A high score indicates better resilience. at Day 0
Secondary 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%). Each work day at the start of the shift. From day 0 to day 30.
Secondary 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%). Every working day at the end of the shift. From day 0 to day 30.
Secondary 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%). Every working day at the end of the shift. From day 0 to day 30.
Secondary 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). at day 30
Secondary overall satisfaction with the stress management training received Scale from 0 to 10 or a higher score indicates a higher level of satisfaction. at day 30
Secondary Have you implemented any of the stress management methods proposed during the training? Yes or No (qualitative) at day 30
Secondary 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 at day 30
Secondary If you used stress management methods: how frequently? choice among : Daily,Weekly,Monthly,The day before an exam,During training periods at day 30
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