Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRBN972020/CHUSTE | Other Identifier | Comité d'éthique |
Not provided
Not provided
The study was stopped due to lack of inclusions
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).
The COVID-19 pandemic and prevention strategise have strongly impacted family lives, social lives, professional lives, and income; resulting in increased reporting of stress and anxiety within patients. This risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social lives. There are evidence showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases.
The COVID-19 pandemic and prevention strategise have strongly impacted family lives and induced a high level of anxiety and other types of stress. This risk of infection 'post-confinement' is an additional source of stress for people returning to their professional and social life.
There are evidences showing a relationship between stress, immunity and the prognosis of several infections and inflammatory diseases.
The aim of this project is to launch an online survey that measures population stress felt during the pandemic and post-confinement time and possible effects on eventual immune mediated disorders (allergies, auto-immunity..) through the report of new events or flares. The stress will first be measured on standardized anxiety GAD-7scale but also on more parameters (ISQ, PHQ-9, PTSD-8, and ECR-S). Socio-economic and environmental parameters will be recorded.
Level of anxiety and other stress parameters as well as occurrence of inflammatory events will be measured according to the calendar and confinement /post confinement timing. Risk factors will be looked for, by multi parametric data analysis.
The survey has been built in a user-friendly, accessible way so the investigators can expect a high number of participants (at least 400), especially as people are highly concerned by the situation and will be motivated to take part.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volunteers | volunteers over 18 years of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generalized Anxiety Disorder-7 (GAD 7) | Diagnostic Test | test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry. |
| Measure | Description | Time Frame |
|---|---|---|
| Results of the Generalized Anxiety Disorder (GAD-7) | test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry. Scored between 0-21: Cut offs:
| 5 Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Results of the Mental Health questionnaire | Welfare effect (mental health positively or negatively affected by COVID-19; why?) Scored between 7-42. These are treated as continuous variables. | 5 minutes |
| Results of the Patient Health Questionnaire (PHQ-9) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Health Volunteers
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claude LAMBERT, MD PhD HDR | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Saint-Etienne | Saint-Etienne | 42270 | France | |||
| Centre de Recherche et d'Innovation Clinique |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Background questionnaire | Diagnostic Test | questionnaire on the living conditions, socio-professional contexts and environmental conditions of the participants |
|
| Impact of COVID-19 questionnaire | Diagnostic Test | status of the patient with regard to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus) |
|
| Confinement and Communication During the COVID-19 Pandemic | Diagnostic Test | know the experience of containment and isolation during the pandemic |
|
| Mental Health questionnaire | Diagnostic Test | welfare effect |
|
| Patient Health Questionnaire (PHQ-9) | Diagnostic Test | assess depression during the pandemic |
|
| Post Traumatic Stress Disorder questionnaire (PTSD-8) | Diagnostic Test | Assessing the trauma of subjects during the pandemic |
|
| Experiences in Close Relationship Scale questionnaire (ECR-S) | Diagnostic Test | Measuring social ties and attachment of subjects |
|
assess depression during the pandemic Scored between 0-27: Cut offs:
|
| 5 minutes |
| Results of the Post Traumatic Stress Disorder (PTSD-8) | Assessing the trauma of subjects during the pandemic Scored between 7-42. These are treated as continuous variables. | 5 minutes |
| Results of the Experiences in Close Relationship Scale questionnaire (ECR-S) | Measuring social ties and attachment of subjects Scored between 7-42. These are treated as continuous variables. | 5 minutes |
| Glasgow |
| United Kingdom |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000086382 | COVID-19 |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided