NCT04301440

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

March 13, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

March 6, 2020

Last Update Submit

April 11, 2023

Conditions

Electromagnetic Emissions and Emotional DisorderElectromagnetic Emissions and Medication Savings

Keywords

AnxietyDepressionQuality of lifeMedication savingsElectromagnetic emissions

Outcome Measures

Primary Outcomes (3)

  • Improved quality of life in depressed and anxiety patients: Hospital Anxiety and Depression scale

    Evaluation with Hospital Anxiety and Depression scale

    Ten days

  • Decreased consumption of anti-anxiety and anti-depressant drugs

    Prescription analysis

    Ten days

  • Improved quality of sleep: Epworth scale

    Evaluation with Epworth scale

    Ten days

Study Arms (2)

patients with anxious and / or depressive characteristics : treated group

ACTIVE COMPARATOR

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

Device: The emission of electromagnetic with the probes

patients with anxious and / or depressive characteristics : placebo group

PLACEBO COMPARATOR

The device with the electromagnetic wave will not be connected

Device: The emission of electromagnetic without the probes

Interventions

The emission of electromagnetic with the probesDEVICE

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.

patients with anxious and / or depressive characteristics : treated group
The emission of electromagnetic without the probesDEVICE

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.

patients with anxious and / or depressive characteristics : placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benkessou

Paris, 75016, France

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study concerns adult patients hospitalized for the management of a chronic pathology and / or its complications
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

March 13, 2020

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

FR(1)