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

Primary Purpose

Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Olfactory aromatherapy
without aromatherapy
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Perioperative Anxiety, Aromatherapy, Surgery, Loco-regional Anesthesia, Ambulatory

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre hospitalierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

aromatherapy group

without aromatherapy

Arm Description

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)

Outcomes

Primary Outcome Measures

Amsterdam Preoperative Anxiety and Information Scale (APAIS) score variation

Secondary Outcome Measures

Anxiety Visual Analogic Scale change after the arrival in the operating room
Satisfaction Visual analogic Scale change after the arrival in the operating theater.
Comfort Visual analogic Scale variation change after the arrival in the operating theater.
Percentage of patients needing a perioperative drug-induced sedation.

Full Information

First Posted
June 28, 2018
Last Updated
October 13, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03583801
Brief Title
Assessment of the Aromatherapy to Alleviate Peri Operative Anxiety in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia
Acronym
AROMA
Official Title
Aromatherapy and Peri Operative Anxiety : Assessment in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia, a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Perioperative Anxiety, Aromatherapy, Surgery, Loco-regional Anesthesia, Ambulatory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
294 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aromatherapy group
Arm Type
Experimental
Arm Description
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)
Arm Title
without aromatherapy
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Olfactory aromatherapy
Other Intervention Name(s)
Inhalation of essential oils
Intervention Description
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..
Intervention Type
Other
Intervention Name(s)
without aromatherapy
Intervention Description
no intervention
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile RIVOAL, MD
Phone
3.27.14.50.61
Ext
+33
Email
rivoal-c@ch-valenciennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile RIVOAL
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier
City
Valenciennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Rivoal, MD

12. IPD Sharing Statement

Learn more about this trial

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

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