Electromagnetic Emissions and Emotional DisorderEPHEMENCT04301440
THE PHYSIOLOGICAL EFFECTS OF ELECTROMAGNETIC EMISSIONS ON THE GENERAL CONDITION OF THE PATIENT
A study testing The emission of electromagnetic with the probes and The emission of electromagnetic without the probes in people with Electromagnetic Emissions and Emotional Disorder and Electromagnetic Emissions and Medication Savings, run by Clinique Bizet at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electromagnetic Emissions and Emotional Disorder, Electromagnetic Emissions and Medication Savings
- What is being tested?
- The emission of electromagnetic with the probes and The emission of electromagnetic without the probes
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2020to 28 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Electromagnetic Emissions and Emotional Disorder, Electromagnetic Emissions and Medication Savings
- Being tested
- The emission of electromagnetic with the probes, The emission of electromagnetic without the probes
- Keywords
- Anxiety, Depression, Quality of life, Medication savings, Electromagnetic emissions
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: The emission of electromagnetic without the probes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved quality of life in depressed and anxiety patients: Hospital Anxiety and Depression scale
Evaluation with Hospital Anxiety and Depression scale
Measured: Ten days
Decreased consumption of anti-anxiety and anti-depressant drugs
Prescription analysis
Measured: Ten days
Improved quality of sleep: Epworth scale
Evaluation with Epworth scale
Measured: Ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start13 Mar 2020
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electromagnetic Emissions and Emotional DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study concerns adult patients hospitalized for the management of a chronic pathology and / or its complications
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301440
- Sponsor's protocol ID
- 2019-A03150-57
- Acronym
- EPHEME
- Status last verified
- Apr 2023
- First submitted
- 6 Mar 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE PHYSIOLOGICAL EFFECTS OF ELECTROMAGNETIC EMISSIONS ON THE GENERAL CONDITION OF THE PATIENT
- ClinicalTrials.gov ID
- NCT04301440
- Acronym / sponsor ID
- EPHEME / 2019-A03150-57
- Conditions
- Electromagnetic Emissions and Emotional Disorder, Electromagnetic Emissions and Medication Savings
- Keywords
- Anxiety, Depression, Quality of life, Medication savings, Electromagnetic emissions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Clinique BizetUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study concerns adult patients hospitalized for the management of a chronic pathology and / or its complications
| Arm | Type | Receives |
|---|---|---|
| patients with anxious and / or depressive characteristics : treated group | Active comparator | Device: The emission of electromagnetic with the probespatients with anxious and / or depressive characteristics, The device with the electromagnetic wave will be connected |
| patients with anxious and / or depressive characteristics : placebo group | Placebo comparator | Device: The emission of electromagnetic without the probesThe device with the electromagnetic wave will not be connected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The emission of electromagnetic with the probesThe 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. | Device | patients with anxious and / or depressive characteristics : treated group |
| The emission of electromagnetic without the probesThe 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. | Device | patients with anxious and / or depressive characteristics : placebo group |
Primary outcome
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
Decreased consumption of anti-anxiety and anti-depressant drugs
Time frame: Ten days
Prescription analysis
Improved quality of sleep: Epworth scale
Time frame: Ten days
Evaluation with Epworth scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The emission of electromagnetic with the probes and The emission of electromagnetic without the probes in people with Electromagnetic Emissions and Emotional Disorder and Electromagnetic Emissions and Medication Savings, run by Clinique Bizet at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved quality of life in depressed and anxiety patients: Hospital Anxiety and Depression scale (time frame: Ten days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.