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Influence of Olfaction Essential Oils on the Consumption of Benzodiazepine Receptor Agonists & Z-Drugs (BZRAs) Prescribed as if Needed in Psychiatric Outpatients (HECBA-PSY).

Influence of Olfaction Essential Oils on the Consumption of Benzodiazepine Receptor Agonists & Z-Drugs (BZRAs) Prescribed as if Needed in Psychiatric Outpatients (HECBA-PSY).

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05583240
Acronym
HECBA-PSY
Enrollment
50
Registered
2022-10-17
Start date
2021-04-19
Completion date
2023-07-30
Last updated
2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benzodiazepine Withdrawal, Psychiatric Disorder

Keywords

Essential Oil, Psychiatry, Olfaction, Anxiety, Insomnia

Brief summary

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.

Detailed description

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.

Interventions

DRUGEssences and Essential Oils

Participants will received Essential Oils through a nasal stick during 4 weeks.

Sponsors

Etablissement Public de Santé Barthélemy Durand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of medications prescribed4 weeksCompare the number of medications prescribed on if needed basis before and after the introduction of essential oils.

Secondary

MeasureTime frameDescription
Anxiety level4 weeksSTAI (State Trait Anxiety Inventory) scale
Sleep level4 weeksPittsburgh Sleep Quality Index (PSQI) scale

Countries

France

Contacts

Primary ContactAdelaide Aduayi
adelaide.aduayi@eps-etampes.fr+33 1 75 02 16 81
Backup ContactMorgane Da Silva Hennequin
morgane.dasilvahennequin@eps-etampes.fr+33 1 82 26 81 08

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026