Evaluation of the Effectiveness of Self-hypnosis on Anxiety and Burnout of Nursing Staff (ESHABC)

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

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Grand-Est
      • Metz, Grand-Est, France, 57085
        • Centre Régional Metz-Thionville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Nursing staff: doctors, nurses or nursing assistants

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nazmine GULER, MD, CHR Metz Thionville Hopital de Mercy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2021

Primary Completion (Actual)

April 13, 2022

Study Completion (Actual)

May 2, 2023

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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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