HypnosisESHABCNCT05143203
Evaluation of the Effectiveness of Self-hypnosis on Anxiety and Burnout of Nursing Staff
An observational study of Hypnosis and Self-hypnosis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypnosis, Self-hypnosis, Anxiety
- What is being tested?
- Self-hypnosis training
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2021to 2 May 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: Nursing staff: doctors, nurses or nursing assistants
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Hypnosis, Self-hypnosis, Anxiety, Depression, Burn Out
- Being tested
- Self-hypnosis training
- Medical subject headings
- Anxiety Disorders, Depression, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-hypnosis trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Staff trained in October 2021 | 22 nursing staff will follow two days of Self-Hypnosis training in October 2021 Receives: Other: Self-hypnosis training | |
| Staff trained in May 2021 | 22 nursing staff will follow two days of Self-Hypnosis training in May 2021 Receives: Other: Self-hypnosis training | |
| Control staff without training | 22 nursing staff will not follow any training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after the training of the training of the first group
Secondary outcomes (17)
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.
Measured: 7 days before the start of the training of the first group
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.
Measured: 1 month after the start of the training of the first group
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.
Measured: 3 months after the start of the training of the first group
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.
Measured: 7 months after the start of the training of the first group
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.
Measured: 12 months after the start of the training of the first group
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.
Measured: 18 months after the start of the training of the first group
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.
Measured: 7 days before the start of the training of the first group
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.
Measured: 1 month after the start of the training of the first group
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.
Measured: 3 months after the start of the training of the first group
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.
Measured: 6 months after the start of the training of the first group
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.
Measured: 7 months after the start of the training of the first group
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.
Measured: 12 months after the start of the training of the first group
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.
Measured: 18 months after the start of the training of the first group
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.
Measured: 7 days before the start of the training of the first group
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.
Measured: 6 Months after the start of the training of the first group
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.
Measured: 12 Months after the start of the training of the first group
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.
Measured: 18 Months after the start of the training of the first group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start12 Oct 2021
- Primary completion13 Apr 2022
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypnosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazmine GULER, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143203
- Sponsor's protocol ID
- 2021-04Obs-CHRMT
- Acronym
- ESHABC
- Status last verified
- Aug 2023
- First submitted
- 22 Nov 2021
- Last updated
- 4 Aug 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 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Self-hypnosis on Anxiety and Burnout of Nursing Staff
- ClinicalTrials.gov ID
- NCT05143203
- Acronym / sponsor ID
- ESHABC / 2021-04Obs-CHRMT
- Conditions
- Hypnosis, Self-hypnosis, Anxiety, Depression, Burn Out
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 3 Dec 2021 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Staff trained in October 2021 | – | Other: Self-hypnosis training22 nursing staff will follow two days of Self-Hypnosis training in October 2021 |
| Staff trained in May 2021 | – | Other: Self-hypnosis training22 nursing staff will follow two days of Self-Hypnosis training in May 2021 |
| Control staff without training | – | –22 nursing staff will not follow any training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nursing staff: doctors, nurses or nursing assistants
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Self-hypnosis trainingSelf-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 | Other | Staff trained in May 2021, Staff trained in October 2021 |
Primary outcome
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
17 secondary outcomes
Anxiety disorder level evaluation D-7
Time frame: 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
Anxiety disorder level evaluation M+3
Time frame: 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
Anxiety disorder level evaluation M+12
Time frame: 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
Depressive disorder evaluation D-7
Time frame: 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
Depressive disorder evaluation M+3
Time frame: 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
Depressive disorder evaluation M+7
Time frame: 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
Depressive disorder evaluation M+18
Time frame: 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
Professional Quality of Life evaluation M+6
Time frame: 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
Professional Quality of Life evaluation M+18
Time frame: 18 Months after the start of the training of the first group
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 4 Aug 2023.
Related trials for Hypnosis
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
Not yet recruiting
Clinical Hypnosis Versus Guided Imagery for Dissociative Symptoms in Adults
Dissociative Symptoms
Not yet recruitingObservational study
Patient State Index at Laryngoscopy and Tracheal Intubation Conditions
Anesthesia, Intubation, Endotracheal
Not yet recruitingObservational study
Feasibility of a Standardized Fascial Plane Block Protocol for Breast Cancer Surgery
Breast Cancer Surgery, Locoregional Anaesthesia
Not yet recruiting
Hypnosis Antalgia Emergency Stitching
Pain Management
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.
Nazmine GULER, MD principal investigator
CHR Metz Thionville Hopital de Mercy
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 Hypnosis and Self-hypnosis, run by Centre Hospitalier Régional Metz-Thionville 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 4 inclusion and 6 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 4 Aug 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?
Anxiety disorder level evaluation M+6 (time frame: 6 months after the training of the training of the first group). 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 4 Aug 2023.