Clinical trial NCT03583801: Assessment of the Aromatherapy to Alleviate Peri Operative Anxiety in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia
Official title: Aromatherapy and Peri Operative Anxiety : Assessment in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia, a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: Perioperative Anxiety
Aromatherapy
Surgery
Loco-regional Anesthesia
Ambulatory
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Amsterdam Preoperative Anxiety and Information Scale (APAIS) score variation
timeFrame: 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:
measure: Anxiety Visual Analogic Scale change after the arrival in the operating room
timeFrame: at baseline and an average at 10 minutes,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room
measure: Satisfaction Visual analogic Scale change after the arrival in the operating theater.
timeFrame: at baseline and an average ,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room
measure: Comfort Visual analogic Scale variation change after the arrival in the operating theater.
timeFrame: at baseline and an average at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room
measure: Percentage of patients needing a perioperative drug-induced sedation.
timeFrame: at baseline and an average ,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room
Other outcomes:
Locations:
city: Valenciennes
country: France
facility: Centre hospitalier
Study officials:
affiliation: University Hospital, Lille
name: Cécile RIVOAL
role: PRINCIPAL_INVESTIGATOR
References: