Assessment of the Aromatherapy to Alleviate Peri Operative Anxiety in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia

Study Overview
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Brief Summary
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AROMA study is a randomised controlled parallel-group single-site study. Patients randomized in the experimental group benefit from the aromatherapy at their arrival in the operating theatre in the recovery room. 2 drops of essential oils are applied on a compress placed next to the head of the patient. This compress is kept until the patient is leaving the operating theatre. Patients randomized in the control group don't benefit from the aromatherapy. The anxiety evolution is measured in both groups with the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The hypothesis is that aromatherapy alleviate peri operative anxiety during an ambulatory elective upper limb surgery under loco-regional anesthesia.

Official Title
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Aromatherapy and Peri Operative Anxiety : Assessment in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia, a Randomized Controlled Study

Conditions
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Anxiety

Intervention / Treatment
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* Other: Olfactory aromatherapy
* Other: without aromatherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient admitted in Hospital Centre for an ambulatory elective upper limb  fast track  surgery Patient with loco-regional anesthesia Patient categorized 3 or less according to the American Society of Anesthesiologists (ASA) score The patient must have given his written consent to participate in the study Patient - insured under the French social security system Patient prepared to comply with all the terms of the study and its length Exclusion Criteria: Epileptic patients Asthmatic patients Patients with cognitive disorders ( Mini Mental Status below 15) Psychiatric disorders : current depression or bipolar disease or anxiety disorders or psychotic disorders according to DSM-V classification American Society of Anesthesiologists score strictly superior to 3 Preoperative chronic pain : neuropathic pain, fibromyalgia, polyarthritis Pregnant or breastfeeding woman Patient unable to receive an informed consent and to comply with all the terms of the study Patient without any social insurance Refusal to sign the consent Patient under legal protection Patient in emergency (unstable clinical state) Patient unable to read or write french Patient enrolled in an other clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aromatherapy group<br>The patient has to choose an essential oil among the 3 proposed : sweet orange (Citrus sinensis L. Persoon) fine lavender (Lavandula angustifolia P. Miller) little seed from the mandarin tree (Citrus reticulata blanco) | Other: Olfactory aromatherapy<br>* 2 drops of the essential oil choosed by the patient are applied on a compress placed next to his head from his arrival in the recovery room to his leaving from the operating theatre. The method of administration is the respiratory tract..<br>* Other names: Inhalation of essential oils;|
| Placebo Comparator: without aromatherapy<br> | Other: without aromatherapy<br>* no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amsterdam Preoperative Anxiety and Information Scale (APAIS) score variation |  | Between time T0 (arrival in the operating room in the recovery room) and time T1 (10 minutes after T0, before loco-regional anesthesia), an average 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Visual Analogic Scale change after the arrival in the operating room |  | at baseline and an average at 10 minutes,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room | 
| Satisfaction Visual analogic Scale change after the arrival in the operating theater. |  | at baseline and an average ,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room | 
| Comfort Visual analogic Scale variation change after the arrival in the operating theater. |  | at baseline and an average at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room | 
| Percentage of patients needing a perioperative drug-induced sedation. |  | at baseline and an average ,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative Anxiety, Aromatherapy, Surgery, Loco-regional Anesthesia, Ambulatory