CompletedNot Applicable

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

France289 participantsStarted 2018-09-14

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Amsterdam Preoperative Anxiety and Information Scale (APAIS) score variation

Timeframe: 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

Trial details

NCT IDNCT03583801

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-14

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