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

Sponsor

University Hospital, Lille (Other)

Overall Status

Unknown status

CT.gov ID

NCT03583801

Collaborator

(none)

294

Enrollment

Location

Arms

35.6

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Other: Olfactory aromatherapy Other: without aromatherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

294 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 14, 2018

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: aromatherapy group 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 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
Placebo Comparator: without aromatherapy	Other: without aromatherapy no intervention

Arm

Intervention/Treatment

Experimental: aromatherapy group

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

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

Placebo Comparator: without aromatherapy

Other: without aromatherapy

no intervention

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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