- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07444255
Comparison of the Effect on Anxiety of Combining Hypnosis and Aromatherapy Through Olfactory Anchoring Versus Standard Care in Patients Undergoing Alcohol Withdrawal (ASHA)
Randomized Trial Comparing the Effect on Anxiety of Combining Hypnosis and Aromatherapy Through Olfactory Anchoring Versus Standard Care in Patients Undergoing Alcohol Withdrawal
According to a meta-analysis published in 2019, hypnosis has demonstrated positive effects in the treatment of certain mental illnesses, particularly anxiety. This technique aims to put the subject into a particular state of consciousness conducive to therapeutic action. The safe place in hypnosis is the basis for anxiety relief work, the first step towards the use of hypnotic metaphors. Smell is an excellent way to stimulate the imagination in creating this safe place.
Anchoring allows the effects of a hypnosis session to be reactivated, enabling the subject to re-experience its benefits through tactile stimulation, a key word, or an image. The investigators use olfactory stimulation as a hypnotic anchor while also utilizing the anxiolytic properties of essential oils.
While there are already studies on the use of hypnosis or aromatherapy in the treatment of patients who use psychotropic drugs, no study to date has focused on their combined use. The innovative aspect of this treatment lies in the prolongation and reinforcement of the effect of the hypnosis session through olfactory stimulation.
The literature shows that memories triggered by a smell have the ability to materialize physiologically in the areas of the brain that process spatial and temporal information. This is also a goal that hypnosis aspires to achieve.
The investigators hypothesize that the use of these two tools in formalized, time-limited nursing interviews can provide patients in the complex withdrawal unit with the means to reduce their anxiety in the short and medium term.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Benoît Lefeuvre
- Phone Number: +33 88 11 66 53
- Email: benoit.lefeuvre@chru-strasbourg.fr
Study Locations
-
-
-
Strasbourg, France
- Hôpitaux Universitaires de Strasbourg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 or over
- Patients hospitalized in an addiction unit for acute alcohol withdrawal and suffering from anxiety disorders
- Patients affiliated with a social security health insurance scheme, beneficiaries or dependents
- Patients who speak/read French, are able to understand the objectives and risks associated with the research, and can give dated and signed informed consent
- Patients who adhere to complementary therapies
- For women of childbearing age, patients for whom the beta HCG test (urine or blood, performed routinely) is negative and who are using effective contraception.
Exclusion Criteria:
- Allergy(ies)/contraindication(s) to essential oils selected for the project
- Patients with psychosis or complex psychological trauma
- Anosmia, hyposmia, or other olfactory disorders limiting the quality of smell
- Asthma
- Ear, nose and throat pathology(ies) contraindicating essential oils in olfaction
- Skepticism regarding the effectiveness of hypnosis and aromatherapy
- Patient under guardianship/curatorship
- Patients excluded from a previous or ongoing study
- Patients in an emergency or life-threatening situation
- Patients under legal guardianship
- Patients who have already participated in this study
- Pregnancy
- Breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Patients Undergoing Alcohol Withdrawal treated by usual treatment
|
Withdrawal care provided according to standard practice
|
|
Experimental: Patients Undergoing Alcohol Withdrawal treated with Hypnosis and Aromatherapy
|
Treatment for withdrawal using hypnosis and aromatherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change of anxiety disorders as assessed by the Hamilton Anxiety Scale between the start and end of the patient's hospitalization.
Time Frame: Day 0 and Day 15
|
Day 0 and Day 15
|
Collaborators and Investigators
Investigators
- Principal Investigator: Benoît Lefeuvre, Hôpitaux Universitaires de Strasbourg
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC25-0040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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