THE PHYSIOLOGICAL EFFECTS OF ELECTROMAGNETIC EMISSIONS ON THE GENERAL CONDITION OF THE PATIENT (EPHEME)

Clinique Bizet

Status: Completed

Conditions: Electromagnetic Emissions and Emotional Disorder; Electromagnetic Emissions and Medication Savings

Treatments: Device: The emission of electromagnetic without the probes; Device: The emission of electromagnetic with the probes

Study type: Interventional

Funder types: Other

Identifiers

NCT04301440

2019-A03150-57

Details and patient eligibility

About

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

Full description

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

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups, including a placebo group

patients with anxious and / or depressive characteristics : treated group

Active Comparator group

Description:

patients with anxious and / or depressive characteristics, The device with the electromagnetic wave will be connected

Treatment:

Device: The emission of electromagnetic with the probes

patients with anxious and / or depressive characteristics : placebo group

Placebo Comparator group

Description:

The device with the electromagnetic wave will not be connected

Treatment:

Device: The emission of electromagnetic without the probes