Influence of Olfaction Essential Oils on the Consumption of Benzodiazepine Receptor Agonists & Z-Drugs (BZRAs) Prescribed as " if Needed " in Psychiatric Outpatients (HECBA-PSY). (HECBA-PSY)
Primary Purpose
Psychiatric Disorder, Benzodiazepine Withdrawal
Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Essences and Essential Oils
Sponsored by
About this trial
This is an interventional treatment trial for Psychiatric Disorder focused on measuring Essential Oil, Psychiatry, Olfaction, Anxiety, Insomnia
Eligibility Criteria
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
Sites / Locations
- Etablissement Public de Santé Barthélemy DurandRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Essential Oils
Arm Description
Outcomes
Primary Outcome Measures
Number of medications prescribed
Compare the number of medications prescribed on "if needed" basis before and after the introduction of essential oils.
Secondary Outcome Measures
Anxiety level
STAI (State Trait Anxiety Inventory) scale
Sleep level
Pittsburgh Sleep Quality Index (PSQI) scale
Full Information
NCT ID
NCT05583240
First Posted
October 13, 2022
Last Updated
October 15, 2022
Sponsor
Etablissement Public de Santé Barthélemy Durand
1. Study Identification
Unique Protocol Identification Number
NCT05583240
Brief 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).
Acronym
HECBA-PSY
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).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
April 18, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Etablissement Public de Santé Barthélemy Durand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder, Benzodiazepine Withdrawal
Keywords
Essential Oil, Psychiatry, Olfaction, Anxiety, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Essential Oils
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Essences and Essential Oils
Intervention Description
Participants will received Essential Oils through a nasal stick during 4 weeks.
Primary Outcome Measure Information:
Title
Number of medications prescribed
Description
Compare the number of medications prescribed on "if needed" basis before and after the introduction of essential oils.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Anxiety level
Description
STAI (State Trait Anxiety Inventory) scale
Time Frame
4 weeks
Title
Sleep level
Description
Pittsburgh Sleep Quality Index (PSQI) scale
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adelaide Aduayi
Phone
+33 1 75 02 16 81
Email
adelaide.aduayi@eps-etampes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Morgane Da Silva Hennequin
Phone
+33 1 82 26 81 08
Email
morgane.dasilvahennequin@eps-etampes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Trichard
Organizational Affiliation
Etablissement Public de Santé Barthélemy Durand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Etablissement Public de Santé Barthélemy Durand
City
Étampes
ZIP/Postal Code
91150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adelaide Aduayi
Phone
+33 1 75 02 16 81
Email
adelaide.aduayi@eps-etampes.fr
First Name & Middle Initial & Last Name & Degree
Morgane Da Silva Hennequin
Phone
+33 1 82 26 81 08
Email
morgane.dasilvahennequin@eps-etampes.fr
First Name & Middle Initial & Last Name & Degree
Christian Trichard
First Name & Middle Initial & Last Name & Degree
Ioana Farcas
12. IPD Sharing Statement
Plan to Share IPD
No
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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).
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