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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A00642-53 | Other Identifier | ID-RCB number, ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aromatherapy group | Experimental | The patient has to choose an essential oil among the 3 proposed :
|
|
| without aromatherapy | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cécile RIVOAL | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier | Valenciennes | France |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019341 | Aromatherapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D008517 | Phytotherapy |
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|
| without aromatherapy | Other | no intervention |
|
| 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 |
| D026421 |
| Sensory Art Therapies |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |