THE PHYSIOLOGICAL EFFECTS OF ELECTROMAGNETIC EMISSIONS ON THE GENERAL CONDITION OF THE PATIENT
NCT ID: NCT04301440
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2020-03-13
2021-05-28
Brief Summary
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The investigator's goal is to use a non-drug approach to these problems which would help improve the quality of life of patients, prevent the consumption of anti-anxiety drugs / antidepressants; and thus to reduce the direct cost in terms of treatment, but also to reduce the indirect costs linked to work stoppages and the consumption of the care offer.
Working hypothesis: Local magnetic muscle stimulation improves people's well-being and relaxation
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Detailed Description
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Describe the effect of the intervention on the level of anxiety / depression in patients with anxious and / or depressive characteristics
Secondary objectives:
* Describe the variation in the quality of life of patients before and after the intervention
* Describe the variation in drug consumption
* Describe the use of post intervention hospitalization
* Describe the variation in the quality of sleep before and after the intervention
* Describe the timeframe for returning patients to professional activity
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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patients with anxious and / or depressive characteristics : treated group
patients with anxious and / or depressive characteristics, The device with the electromagnetic wave will be connected
The emission of electromagnetic with the probes
The patient will be in the lying position, a probe will be positioned in the middle of the chest and the second probe below the xyphoid. The probes will be fixed by a band to keep them in place. The emission of electromagnetic waves is painless.
patients with anxious and / or depressive characteristics : placebo group
The device with the electromagnetic wave will not be connected
The emission of electromagnetic without the probes
The patient will be in the lying position, a probe will be positioned in the middle of the chest and the second probe below the xyphoid. The probes will be fixed by a band to keep them in place. The emission of electromagnetic waves is painless.
Interventions
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The emission of electromagnetic with the probes
The patient will be in the lying position, a probe will be positioned in the middle of the chest and the second probe below the xyphoid. The probes will be fixed by a band to keep them in place. The emission of electromagnetic waves is painless.
The emission of electromagnetic without the probes
The patient will be in the lying position, a probe will be positioned in the middle of the chest and the second probe below the xyphoid. The probes will be fixed by a band to keep them in place. The emission of electromagnetic waves is painless.
Eligibility Criteria
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Inclusion Criteria
* Patient with a Hospital Anxiety and Depression scale score (HAD) ≥ 8 for items assessing anxiety disorders; AND a HAD score ≥ 8 for the items assessing depressive disorders.
* Subject affiliated to a social security scheme or beneficiary of such a scheme
* No participation in another clinical study
Exclusion Criteria
* Pregnant and breastfeeding women
* HAD score \<8 for items evaluating anxiety disorders OR a HAD score \<8 for items evaluating depressive disorders
* Major subject protected by law, under curatorship or tutorship
18 Years
ALL
No
Sponsors
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Clinique Bizet
OTHER
Responsible Party
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Locations
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Benkessou
Paris, , France
Countries
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Other Identifiers
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2019-A03150-57
Identifier Type: -
Identifier Source: org_study_id
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