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

April 11, 2023 updated by: Clinique Bizet

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75016
        • Benkessou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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.
Placebo Comparator: patients with anxious and / or depressive characteristics : placebo group
The device with the electromagnetic wave will not be connected
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Bizet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2020

Primary Completion (Actual)

May 28, 2021

Study Completion (Actual)

May 28, 2021

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-A03150-57

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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