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

NCT05583240 | Unknown Phase 4

• 2 other identifiers: 21P012019-A02345-52
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychiatric Disorder; Benzodiazepine Withdrawal

Keywords

Essential Oil; Psychiatry; Olfaction; Anxiety; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anxiety level

  4 weeks

• Sleep level

  4 weeks

Study Arms (1)

Essential Oils

EXPERIMENTAL

Drug: Essences and Essential Oils

Interventions

Essences and Essential Oils DRUG

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

Essential Oils

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Etablissement Public de Santé Barthélemy Durand: lead

Study Sites (1)

Etablissement Public de Santé Barthélemy Durand

Étampes, 91150, France

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Anosmia; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Oils, Volatile

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Christian Trichard

  Etablissement Public de Santé Barthélemy Durand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: April 19, 2021
• Primary Completion: April 18, 2023
• Study Completion: July 30, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)