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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02345-52 | Registry Identifier | ANSM |
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The goal of this interventional study is to test the use of olfactory Essential Oils through a nasal stick as one of the non-medicinal strategies to propose to the patient to reduce the consumption of medication in a population of stabilized patients with psychiatric disorder.
The main objective is to evaluate whether the olfaction of a mixture of essential oils can reduce the intake of BZRAs, prescribed if needed.
The investigators want to compare the number of medications prescribed on "if needed" basis before and after the introduction of Essential Oils.
A period prior to inclusion is used to assess the participant's frequency of BZRA use. Then, participants will received Essential Oils through a nasal stick during 4 weeks. During this period, the patient completes weekly anxiety and sleep scales and at the final visit, weekly and monthly anxiety and sleep scales.
It is a common in psychiatry for a physician to prescribe a patient, regardless of pathology, a treatment to be taken punctually in case of anxiety, nervousness, irritability or difficulty falling asleep. This "if needed" treatment can be add to the patient's usual treatment or constitute his only drug treatment.
Most of the time, the "if needed" medication prescribed is a BZRA, which exposes the patient to the risk of creating dependency and drug abuse if the doses are multiplied.
In this context, it seems interesting to us to test the use of olfactory Essential Oils through a nasal stick as one of the non-medicinal strategies to propose to the patient to reduce the consumption of medication.
A two-week period prior to inclusion is used to assess the patient's frequency of BZRA use.
During the pre-inclusion visit, the investigators explain the study protocol, the patient gives consent, and they are given a diary to record their BZRA use.
(one of the inclusion criteria is more than 3 and less than 21).
At the second visit, the patient fills out the anxiety and sleep questionnaire, the investigators perform an allergy test, and they receive an aromastick.
At following visits, the patient completes weekly anxiety and sleep scales and at the final visit, weekly and monthly anxiety and sleep scales.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essential Oils | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Essences and Essential Oils | Drug | Participants will received Essential Oils through a nasal stick during 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of medications prescribed | Compare the number of medications prescribed on "if needed" basis before and after the introduction of essential oils. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety level | STAI (State Trait Anxiety Inventory) scale | 4 weeks |
| Sleep level | Pittsburgh Sleep Quality Index (PSQI) scale | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adelaide Aduayi | Contact | +33 1 75 02 16 81 | adelaide.aduayi@eps-etampes.fr | |
| Morgane Da Silva Hennequin | Contact | +33 1 82 26 81 08 | morgane.dasilvahennequin@eps-etampes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christian Trichard | Etablissement Public de Santé Barthélemy Durand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Etablissement Public de Santé Barthélemy Durand | Recruiting | Étampes | 91150 | France |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000086582 | Anosmia |
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D009822 | Oils, Volatile |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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