AnxietyAROMANCT03583801
Assessment of the Aromatherapy to Alleviate Peri Operative Anxiety in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia
A study testing Olfactory aromatherapy and without aromatherapy in people with Anxiety, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Olfactory aromatherapy and without aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 289 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2018to 14 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anxiety
- Being tested
- Olfactory aromatherapy, without aromatherapy
- Keywords
- Perioperative Anxiety, Aromatherapy, Surgery, Loco-regional Anesthesia, Ambulatory
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory aromatherapyOther
Also called Inhalation of essential oils
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 aromatherapyOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Olfactory aromatherapy |
| without aromatherapy | Placebo comparator | Not described Receives: Other: without aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amsterdam Preoperative Anxiety and Information Scale (APAIS) score variation
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline and an average ,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start14 Sep 2018
- Primary completion14 Sep 2024
- Study completion14 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile RIVOAL, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583801
- Sponsor's protocol ID
- 2017_58
- Other IDs
- 2018-A00642-53
- Acronym
- AROMA
- Status last verified
- May 2026
- First submitted
- 28 Jun 2018
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy and Peri Operative Anxiety : Assessment in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia, a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03583801
- Acronym / sponsor ID
- AROMA / 2017_58
- Conditions
- Anxiety
- Keywords
- Perioperative Anxiety, Aromatherapy, Surgery, Loco-regional Anesthesia, Ambulatory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 14 Sep 2024 (actual)
- Study completion
- 14 Sep 2024 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aromatherapy group | Experimental | Other: Olfactory aromatherapyThe 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) |
| without aromatherapy | Placebo comparator | Other: without aromatherapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olfactory aromatherapyAlso: Inhalation of essential oils2 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 | aromatherapy group |
| without aromatherapyno intervention | Other | without aromatherapy |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile RIVOAL principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olfactory aromatherapy and without aromatherapy in people with Anxiety, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.