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

Not Applicable

Completed

• Conditions: Electromagnetic Emissions and Emotional Disorder; Electromagnetic Emissions and Medication Savings
• Interventions: Device: The emission of electromagnetic with the probes; Device: The emission of electromagnetic without the probes

• Registration Number: NCT04301440
• Lead Sponsor: Clinique Bizet

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-10
• Study Start: 2020-03-13
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with anxious and / or depressive characteristics : treated group	The emission of electromagnetic with the probes	patients with anxious and / or depressive characteristics, The device with the electromagnetic wave will be connected
patients with anxious and / or depressive characteristics : placebo group	The emission of electromagnetic without the probes	The device with the electromagnetic wave will not be connected

Primary Outcome Measures

Name	Time	Method
Improved quality of life in depressed and anxiety patients: Hospital Anxiety and Depression scale	Ten days	Evaluation with Hospital Anxiety and Depression scale
Decreased consumption of anti-anxiety and anti-depressant drugs	Ten days	Prescription analysis
Improved quality of sleep: Epworth scale	Ten days	Evaluation with Epworth scale

Trial Locations

Locations (1)

Benkessou; 🇫🇷 Paris, France