NCT05583240

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Etablissement Public de Santé Barthélemy Durand · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychiatric Disorder
• Benzodiazepine Withdrawal

Interventions

Type	Name	Description
DRUG	Essences and Essential Oils	Participants will received Essential Oils through a nasal stick during 4 weeks.

Timeline

• Start date: 2021-04-19
• Primary completion: 2023-04-18
• Completion: 2023-07-30
• First posted: 2022-10-17
• Last updated: 2022-10-18

Locations

1 site across 1 country: France