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

NCT ID: NCT03583801

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-14
• Study Completion Date: 2023-09-30

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aromatherapy group

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)

Group Type: EXPERIMENTAL

Olfactory aromatherapy

Intervention Type: OTHER

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..

without aromatherapy

Group Type: PLACEBO_COMPARATOR

without aromatherapy

Intervention Type: OTHER

no intervention

Interventions

Olfactory aromatherapy

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..

Intervention Type: OTHER

without aromatherapy

no intervention

Intervention Type: OTHER

Other Intervention Names

Inhalation of essential oils

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cécile RIVOAL

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Centre hospitalier

Valenciennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Cécile RIVOAL, MD

Role: CONTACT

rivoal-c@ch-valenciennes.fr

3.27.14.50.61 ext. +33

Other Identifiers

2018-A00642-53

Identifier Type: OTHER

Identifier Source: secondary_id

2017_58

Identifier Type: -

Identifier Source: org_study_id