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

May 20, 2026 updated by: University Hospital, Lille

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

289

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Valenciennes, France
        • Centre Hospitalier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Other: 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..
Other Names:
  • Inhalation of essential oils
Placebo Comparator: without aromatherapy
Other: without aromatherapy
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame
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
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
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
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.
Time Frame: at baseline and an average ,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room
at baseline and an average ,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Cécile RIVOAL, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2018

Primary Completion (Actual)

September 14, 2024

Study Completion (Actual)

September 14, 2024

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_58
  • 2018-A00642-53 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on Olfactory aromatherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe