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

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ClinicalTrials.gov Identifier: NCT03583801
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 14, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: Inhalation of essential oils

Placebo Comparator: without aromatherapy Other: without aromatherapy
no intervention




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583801


Contacts
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Contact: Cécile RIVOAL, MD 3.27.14.50.61 ext +33 rivoal-c@ch-valenciennes.fr

Locations
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France
Centre hospitalier Recruiting
Valenciennes, France
Principal Investigator: Cécile Rivoal, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Cécile RIVOAL University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03583801     History of Changes
Other Study ID Numbers: 2017_58
2018-A00642-53 ( Other Identifier: ID-RCB number, ANSM )
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Perioperative Anxiety
Aromatherapy
Surgery
Loco-regional Anesthesia
Ambulatory

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs