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

Anxiety Clinical Trial

— AROMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03583801
• Other study ID #: 2017_58
• Secondary ID: 2018-A00642-53
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2018
• Est. completion date: September 2023

Study information

• Verified date: October 2022
• Source: University Hospital, Lille
• Contact: Cécile RIVOAL, MD
• Phone: 3.27.14.50.61
• Email: rivoal-c[@]ch-valenciennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 294
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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..
• without aromatherapy
no intervention

Locations

Country	Name	City	State
France	Centre hospitalier	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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