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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05143203
Other study ID # 2021-04Obs-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 12, 2021
Est. completion date May 2, 2023

Study information

Verified date August 2023
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Its a prospective, non-interventional, single-center study, involving the human person evaluating the impact of self-hypnosis training on anxiety level and burn out in nursing and medical staff


Description:

Like other pandemics, that of Covid-19 had a significant psychological impact on the general population. However, this impact turned out to be even more acute among healthcare workers, in connection with repeated exposure to the risk of infection, the reorganization of care and their specific positioning (...) Psychotraumatic, anxiety and depression symptoms has been observed worldwide. The staff of CHR Metz-Thionville were not spared. From the first wave, the caregivers exposed directly to SARS-CoV-2 (emergency, resuscitation, cohorting sector) requested the hypnosis referent doctor of the structure, in order to benefit from hypnosis sessions in order to better manage their anxiety during the sanitary crisis. The main demand from caregivers was learning stress management tools and a desire for empowerment without psychological support. For information, the support platform set up by the psychiatry service recorded very few calls (39 caregivers from March 24, 2020 to June 26, 2020). Faced with the influx of hypnotherapy requests, the training unit was asked to set up on-site self-hypnosis training. It seemed important to measure the effect of this learning on the mental health of caregivers using psychometric scales. This training was initially offered to front-line caregivers in the fight against the covid-19 pandemic and by extension to all caregivers wishing to be trained in this practice. It is obvious that this pandemic may have worsened a general ill-being of caregivers already present before the current health crisis. There are many studies on the management of anxiety and pain in patients with a history of chronic disease, and some have focused specifically on learning self-hypnosis techniques. Even if the protocols for learning self-hypnosis techniques are very heterogeneous in these various pathologies, there is a common observation : "studies show positive results on self-esteem, catastrophism, depression, quality of sleep , the somatizations, the anxiety of the patients (and of their parents for the children), mood ". To date, and to our knowledge, there are no methodologically rigorous studies measuring the effects of hypnosis or self-hypnosis on the mental health of caregivers. Publications are often limited to clinical cases or positions related to the use of hypnosis and / or self-hypnosis for the well-being of caregivers.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date May 2, 2023
Est. primary completion date April 13, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Nursing staff of the CHR Metz-Thionville: doctors, nurses or nursing assistants - Over 18 years old - Not objecting to participating in the study - Affiliated to a social security scheme Exclusion Criteria: Hospital staff - Not speaking and/or not understanding the French language. - Having disorders of higher functions. - With known history of schizophrenia. - Deaf or hard of hearing. - already trained in hypnosis.

Study Design


Intervention

Other:
Self-hypnosis training
Self-hypnosis training will be conducted in two phases and the evaluation of effectiveness of the training will be measured using GAD7, PHQ9 and PROQOL questionnaires

Locations

Country Name City State
France Centre Régional Metz-Thionville Metz Grand-Est

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety disorder level evaluation M+6 Generalized anxiety disorder screening scale (GAD7) will be measured 6 months after the start of training in self-hypnosis 6 months after the training of the training of the first group
Secondary Anxiety disorder level evaluation D-7 Generalized anxiety disorder screening scale (GAD7) The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
7 days before the start of the training of the first group
Secondary Anxiety disorder level evaluation M+1 Generalized anxiety disorder screening scale (GAD7) The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
1 month after the start of the training of the first group
Secondary Anxiety disorder level evaluation M+3 Generalized anxiety disorder screening scale (GAD7) The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
3 months after the start of the training of the first group
Secondary Anxiety disorder level evaluation M+7 Generalized anxiety disorder screening scale (GAD7) The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
7 months after the start of the training of the first group
Secondary Anxiety disorder level evaluation M+12 Generalized anxiety disorder screening scale (GAD7) The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
12 months after the start of the training of the first group
Secondary Anxiety disorder level evaluation M+18 Generalized anxiety disorder screening scale (GAD7) The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
18 months after the start of the training of the first group
Secondary Depressive disorder evaluation D-7 The Patient Health Questionnaire 9-item depression module (PHQ-9) will be used to measure depression disorder of nursing staff 7 days before the start of self-hypnosis training.
PHQ-9 is a well-validated, brief, self-reported, diagnostic, and severity measure of depression designed for use in primary care.
7 days before the start of the training of the first group
Secondary Depressive disorder evaluation M+1 The Patient Health Questionnaire 9-item depression module (PHQ-9) will be used to measure depression disorder of nursing staff 1 month after the start of self-hypnosis training PHQ-9 is a well-validated, brief, self-reported, diagnostic, and severity measure of depression designed for use in primary care. 1 month after the start of the training of the first group
Secondary Depressive disorder evaluation M+3 The Patient Health Questionnaire 9-item depression module (PHQ-9) will be used to measure depression disorder of nursing staff 3 months after the start of self-hypnosis training PHQ-9 is a well-validated, brief, self-reported, diagnostic, and severity measure of depression designed for use in primary care. 3 months after the start of the training of the first group
Secondary Depressive disorder evaluation M+6 The Patient Health Questionnaire 9-item depression module (PHQ-9) will be used to measure depression disorder of nursing staff 6 months after the start of self-hypnosis training PHQ-9 is a well-validated, brief, self-reported, diagnostic, and severity measure of depression designed for use in primary care. 6 months after the start of the training of the first group
Secondary Depressive disorder evaluation M+7 The Patient Health Questionnaire 9-item depression module (PHQ-9) will be used to measure depression disorder of nursing staff 7 months after the start of self-hypnosis training PHQ-9 is a well-validated, brief, self-reported, diagnostic, and severity measure of depression designed for use in primary care. 7 months after the start of the training of the first group
Secondary Depressive disorder evaluation M+12 The Patient Health Questionnaire 9-item depression module (PHQ-9) will be used to measure depression disorder of nursing staff 12 months after the start of self-hypnosis training PHQ-9 is a well-validated, brief, self-reported, diagnostic, and severity measure of depression designed for use in primary care. 12 months after the start of the training of the first group
Secondary Depressive disorder evaluation M+18 The Patient Health Questionnaire 9-item depression module (PHQ-9) will be used to measure depression disorder of nursing staff 18 months after the start of self-hypnosis training PHQ-9 is a well-validated, brief, self-reported, diagnostic, and severity measure of depression designed for use in primary care. 18 months after the start of the training of the first group
Secondary Professional Quality of Life evaluation D-7 The Professional Quality of Life Scale (ProQOL) is a 30 item self-report questionnaire designed to measure compassion fatigue, work satisfaction and burnout in helping professionals. Helping professionals are defined broadly, from those in health care settings, such as psychologists, nurses and doctors. It is useful for workers who perform emotional labour as well as professionals who are exposed to traumatic situations. Raw scores between 10 and 50 are presented for the three subscales (1) Compassion Satisfaction, (2) Burnout and (3) Secondary Traumatic Stress. Each score is also presented as a percentile rank comparing the respondent's scores to scores of helping professionals generally (such as psychologists, doctors, teachers and first responders). A percentile of 50 represents an average score. High scores on Compassion Satisfaction and low scores on Burnout and Secondary Traumatic Stress are indicative of professional health. 7 days before the start of the training of the first group
Secondary Professional Quality of Life evaluation M+6 The Professional Quality of Life Scale (ProQOL) is a 30 item self-report questionnaire designed to measure compassion fatigue, work satisfaction and burnout in helping professionals. Helping professionals are defined broadly, from those in health care settings, such as psychologists, nurses and doctors. It is useful for workers who perform emotional labour as well as professionals who are exposed to traumatic situations. Raw scores between 10 and 50 are presented for the three subscales (1) Compassion Satisfaction, (2) Burnout and (3) Secondary Traumatic Stress. Each score is also presented as a percentile rank comparing the respondent's scores to scores of helping professionals generally (such as psychologists, doctors, teachers and first responders). A percentile of 50 represents an average score. High scores on Compassion Satisfaction and low scores on Burnout and Secondary Traumatic Stress are indicative of professional health. 6 Months after the start of the training of the first group
Secondary Professional Quality of Life evaluation M+12 The Professional Quality of Life Scale (ProQOL) is a 30 item self-report questionnaire designed to measure compassion fatigue, work satisfaction and burnout in helping professionals. Helping professionals are defined broadly, from those in health care settings, such as psychologists, nurses and doctors. It is useful for workers who perform emotional labour as well as professionals who are exposed to traumatic situations. Raw scores between 10 and 50 are presented for the three subscales (1) Compassion Satisfaction, (2) Burnout and (3) Secondary Traumatic Stress. Each score is also presented as a percentile rank comparing the respondent's scores to scores of helping professionals generally (such as psychologists, doctors, teachers and first responders). A percentile of 50 represents an average score. High scores on Compassion Satisfaction and low scores on Burnout and Secondary Traumatic Stress are indicative of professional health. 12 Months after the start of the training of the first group
Secondary Professional Quality of Life evaluation M+18 The Professional Quality of Life Scale (ProQOL) is a 30 item self-report questionnaire designed to measure compassion fatigue, work satisfaction and burnout in helping professionals. Helping professionals are defined broadly, from those in health care settings, such as psychologists, nurses and doctors. It is useful for workers who perform emotional labour as well as professionals who are exposed to traumatic situations. Raw scores between 10 and 50 are presented for the three subscales (1) Compassion Satisfaction, (2) Burnout and (3) Secondary Traumatic Stress. Each score is also presented as a percentile rank comparing the respondent's scores to scores of helping professionals generally (such as psychologists, doctors, teachers and first responders). A percentile of 50 represents an average score. High scores on Compassion Satisfaction and low scores on Burnout and Secondary Traumatic Stress are indicative of professional health. 18 Months after the start of the training of the first group
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