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OpenTrials
Completed

NCT Number: NCT04301440

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

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

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Key information

Conditions

Electromagnetic Emissions and Emotional Disorder Anxiety Disorders Behavior Behavioral Symptoms Depression Electromagnetic Emissions and Medication Savings Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benkessou

Paris, 75016, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The emission of electromagnetic with the probes

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.

The emission of electromagnetic without the probes

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.

Primary outcomes

  1. 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

  2. Decreased consumption of anti-anxiety and anti-depressant drugs

    Time frame: Ten days

    Prescription analysis

  3. Improved quality of sleep: Epworth scale

    Time frame: Ten days

    Evaluation with Epworth scale

Sponsors and collaborators

Lead sponsor

Clinique Bizet

Other

Registry information

Acronym: EPHEME

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2020
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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