Psychiatric Disorder Clinical Trial
— HECBA-PSYOfficial title:
Influence of Olfaction Essential Oils on the Consumption of Benzodiazepine Receptor Agonists & Z-Drugs (BZRAs) Prescribed as " if Needed " in Psychiatric Outpatients (HECBA-PSY).
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 30, 2023 |
Est. primary completion date | April 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Adult without legal protection measures - Ambulatory followed up - Stabilised main psychiatric pathology - Patient having had recourse between 3 and 21 times a week in the previous 14 days to a benzodiazepine or related treatment, for anxiolytic or hypnotic purposes, prescribed "if necessary" (on request) - Patient who understand French both orally and in writing - Patient who do not have an identified organic cause for their disorder - Patient who be affiliated to a social security scheme - Patient who have given their free and informed consent and signed the consent form Exclusion Criteria: - Patients with asthma or unstable epilepsy - Pregnancy or breastfeeding - EO allergies - Patients having already a regular consumption of EO for the study indication - Patients under guardianship or under reinforced guardianship |
Country | Name | City | State |
---|---|---|---|
France | Etablissement Public de Santé Barthélemy Durand | Étampes |
Lead Sponsor | Collaborator |
---|---|
Etablissement Public de Santé Barthélemy Durand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of medications prescribed | Compare the number of medications prescribed on "if needed" basis before and after the introduction of essential oils. | 4 weeks | |
Secondary | Anxiety level | STAI (State Trait Anxiety Inventory) scale | 4 weeks | |
Secondary | Sleep level | Pittsburgh Sleep Quality Index (PSQI) scale | 4 weeks |
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