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

Electromagnetic Emissions and Emotional Disorder Clinical Trial

— EPHEME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301440
• Other study ID #: 2019-A03150-57
• Status: Completed
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: April 2023
• Source: Clinique Bizet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Electromagnetic Emissions and Emotional Disorder
• Electromagnetic Emissions and Medication Savings

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Benkessou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Bizet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved quality of life in depressed and anxiety patients: Hospital Anxiety and Depression scale	Evaluation with Hospital Anxiety and Depression scale	Ten days
Primary	Decreased consumption of anti-anxiety and anti-depressant drugs	Prescription analysis	Ten days
Primary	Improved quality of sleep: Epworth scale	Evaluation with Epworth scale	Ten days