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

NCT03583801 | Completed

• 2 other identifiers: 2017_582018-A00642-53
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 1

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

Keywords

Perioperative Anxiety; Aromatherapy; Surgery; Loco-regional Anesthesia; Ambulatory

Outcome Measures

Primary Outcomes (1)

• Amsterdam Preoperative Anxiety and Information Scale (APAIS) score variation

  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 (4)

• Anxiety Visual Analogic Scale change after the arrival in the 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.

  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.

  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.

  at baseline and an average ,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room

Study Arms (2)

aromatherapy group

EXPERIMENTAL

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

without aromatherapy

PLACEBO COMPARATOR

Other: without aromatherapy

Interventions

Olfactory aromatherapy 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..

Also known as: Inhalation of essential oils

aromatherapy group

without aromatherapy OTHER

no intervention

without aromatherapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Centre hospitalier

Valenciennes, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Cécile RIVOAL

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 11, 2018
• Study Start: September 14, 2018
• Primary Completion: September 14, 2024
• Study Completion: September 14, 2024
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

FR (1)