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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05583240
Other study ID # 21P01
Secondary ID 2019-A02345-52
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 19, 2021
Est. completion date July 30, 2023

Study information

Verified date October 2022
Source Etablissement Public de Santé Barthélemy Durand
Contact Adelaide Aduayi
Phone +33 1 75 02 16 81
Email adelaide.aduayi@eps-etampes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Essences and Essential Oils
Participants will received Essential Oils through a nasal stick during 4 weeks.

Locations

Country Name City State
France Etablissement Public de Santé Barthélemy Durand Étampes

Sponsors (1)

Lead Sponsor Collaborator
Etablissement Public de Santé Barthélemy Durand

Country where clinical trial is conducted

France, 

Outcome

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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