THE PHYSIOLOGICAL EFFECTS OF ELECTROMAGNETIC EMISSIONS ON THE GENERAL CONDITION OF THE PATIENT

NCT ID: NCT04301440

Last Updated: 2023-04-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-13

Study Completion Date

2021-05-28

Brief Summary

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Hospital patients usually experience anxiety caused by physiological, psychological and environmental stimuli. This emotional state corresponds to the psychophysiological response to a perceived threat.

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

Detailed Description

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Primary objective :

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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Electromagnetic Emissions and Emotional Disorder Electromagnetic Emissions and Medication Savings

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The study concerns adult patients hospitalized for the management of a chronic pathology and / or its complications
Primary Study Purpose

OTHER

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

The emission of electromagnetic with the probes

Intervention Type DEVICE

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

Group Type PLACEBO_COMPARATOR

The emission of electromagnetic without the probes

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Major patient hospitalized for the management of a chronic pathology and / or its complications;
* 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

* Minor patient
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Bizet

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Benkessou

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2019-A03150-57

Identifier Type: -

Identifier Source: org_study_id

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