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

University Hospital, Lille

Status: Enrolling

Conditions: Anxiety

Treatments: Other: without aromatherapy; Other: Olfactory aromatherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03583801

2018-A00642-53 (Other Identifier)

2017_58

Details and patient eligibility

About

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.

Enrollment: 294 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

294 participants in 2 patient groups, including a placebo group

aromatherapy group

Experimental group

Description:

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)

Treatment:

Other: Olfactory aromatherapy

without aromatherapy

Placebo Comparator group

Treatment:

Other: without aromatherapy