- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05143203
Evaluation of the Effectiveness of Self-hypnosis on Anxiety and Burnout of Nursing Staff (ESHABC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Grand-Est
-
Metz, Grand-Est, France, 57085
- Centre Régional Metz-Thionville
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Staff trained in October 2021
22 nursing staff will follow two days of Self-Hypnosis training in October 2021
|
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
|
|
Staff trained in May 2021
22 nursing staff will follow two days of Self-Hypnosis training in May 2021
|
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
|
|
Control staff without training
22 nursing staff will not follow any training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety disorder level evaluation M+6
Time Frame: 6 months after the training of the training of the first group
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety disorder level evaluation D-7
Time Frame: 7 days before the start of the training of the first group
|
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
|
|
Anxiety disorder level evaluation M+1
Time Frame: 1 month after the start of the training of the first group
|
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
|
|
Anxiety disorder level evaluation M+3
Time Frame: 3 months after the start of the training of the first group
|
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
|
|
Anxiety disorder level evaluation M+7
Time Frame: 7 months after the start of the training of the first group
|
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
|
|
Anxiety disorder level evaluation M+12
Time Frame: 12 months after the start of the training of the first group
|
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
|
|
Anxiety disorder level evaluation M+18
Time Frame: 18 months after the start of the training of the first group
|
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
|
|
Depressive disorder evaluation D-7
Time Frame: 7 days before the start of the training of the first group
|
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
|
|
Depressive disorder evaluation M+1
Time Frame: 1 month after the start of the training of the first group
|
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
|
|
Depressive disorder evaluation M+3
Time Frame: 3 months after the start of the training of the first group
|
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
|
|
Depressive disorder evaluation M+6
Time Frame: 6 months after the start of the training of the first group
|
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
|
|
Depressive disorder evaluation M+7
Time Frame: 7 months after the start of the training of the first group
|
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
|
|
Depressive disorder evaluation M+12
Time Frame: 12 months after the start of the training of the first group
|
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
|
|
Depressive disorder evaluation M+18
Time Frame: 18 months after the start of the training of the first group
|
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
|
|
Professional Quality of Life evaluation D-7
Time Frame: 7 days before the start of the training of the first group
|
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
|
|
Professional Quality of Life evaluation M+6
Time Frame: 6 Months after the start of the training of the first group
|
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
|
|
Professional Quality of Life evaluation M+12
Time Frame: 12 Months after the start of the training of the first group
|
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
|
|
Professional Quality of Life evaluation M+18
Time Frame: 18 Months after the start of the training of the first group
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nazmine GULER, MD, CHR Metz Thionville Hopital de Mercy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-04Obs-CHRMT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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