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Completed

NCT Number: NCT03583801

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier

Valenciennes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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..

Other names: Inhalation of essential oils

without aromatherapy

Other

no intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: AROMA

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2018
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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