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

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



Sponsors


Source

University Hospital, Lille

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2018-09-01

Completion Date

2019-11-01

Primary Completion Date

2019-11-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

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 min

Secondary Outcome

Measure

Time Frame

Anxiety Visual Analogic Scale change after the arrival in the operating room
at baseline and an average at 10 min,at 35 min, at 70 min 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 min, at 70 min 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 min, at 70 min 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 min, at 70 min and at 3 hours after arriving in operating room

Enrollment

294

Condition


Intervention

Intervention Type

Other

Intervention Name


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..

Arm Group Label

aromatherapy group

Other Name

Inhalation of essential oils


Intervention Type

Other

Intervention Name


Description

no intervention

Arm Group Label

without aromatherapy



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

Gender

All

Minimum Age

18 Years

Maximum Age

90 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Cécile RIVOAL
Principal Investigator
University Hospital, Lille

Overall Contact

Last Name

Cécile RIVOAL, MD

Phone

3.27.14.50.61

Phone Ext

+33

Email

rivoal-c@ch-valenciennes.fr


Verification Date

2018-06-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Secondary Id

2018-A00642-53

Number Of Arms

2

Intervention Browse

Mesh Term

Anesthetics


Arm Group

Arm Group Label

aromatherapy group

Arm Group Type

Experimental

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 Group Label

without aromatherapy

Arm Group Type

Placebo Comparator



Firstreceived Results Date

N/A

Acronym

AROMA

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

June 28, 2018

Study First Submitted Qc

July 10, 2018

Study First Posted

July 11, 2018

Last Update Submitted

July 10, 2018

Last Update Submitted Qc

July 10, 2018

Last Update Posted

July 11, 2018


ClinicalTrials.gov processed this data on August 23, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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