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

University Hospital, Lille294 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

294

Conditions

Anxiety

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Amsterdam Preoperative Anxiety and Information Scale (APAIS) score variation

Time frame: 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 Outcomes

Anxiety Visual Analogic Scale change after the arrival in the operating room

Time frame: 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.

Time frame: 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.

Time frame: 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.