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

Sponsor

Etablissement Public de Santé Barthélemy Durand (Other)

Overall Status

Recruiting

CT.gov ID

NCT05583240

Collaborator

(none)

Enrollment

Location

Arm

27.3

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychiatric Disorder Benzodiazepine Withdrawal	Drug: Essences and Essential Oils	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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).

Actual Study Start Date :

Apr 19, 2021

Anticipated Primary Completion Date :

Apr 18, 2023

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Essential Oils	Drug: Essences and Essential Oils Participants will received Essential Oils through a nasal stick during 4 weeks.

Arm

Intervention/Treatment

Experimental: Essential Oils

Drug: Essences and Essential Oils

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

Outcome Measures

Primary Outcome Measures

Number of medications prescribed [4 weeks]
Compare the number of medications prescribed on "if needed" basis before and after the introduction of essential oils.

Secondary Outcome Measures

Anxiety level [4 weeks]
STAI (State Trait Anxiety Inventory) scale
Sleep level [4 weeks]
Pittsburgh Sleep Quality Index (PSQI) scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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