Anxiolytic Effect of Lavender Oil on Orthognathic Surgery Patients

NCT ID: NCT03388736

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-03-01

Brief Summary

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The aim of this study is to determine the possible reducing effects of different concentrations of lavender oil on preoperative anxiety in orthognathic surgery patients who have high anxiety during preoperative wait.

Detailed Description

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Preoperative anxiety is a common problem. It has long been known that surgical operations, unconsciousness, the risks of the operation itself, and the pain to be encountered in the future can cause a considerable amount of anxiety. Anxiety is associated with an uncertain psychological distress, and may vary to minor disturbances to extreme stress. Depending on the severity of the anxiety, preoperative anxiety can affect how well the patient understands the information about the surgery. In addition, stress factors such as interleukins released in the body in anxiety may negatively affect both surgical and post-surgical periods. We want to help patients improve their satisfaction by reducing their anxiety levels and ensure they have a better surgical experience. In addition, anxiety can also prevent active participation in the treatment of the patient during postoperative recovery. Sedatives and other anxiolytic agents may be prescribed to prevent this condition. However, these methods can have side effects. The physical and psychological effects of essential oils and traditional medicine practices as aromatherapy has been used for a long time and has potency to reduce using sedatives. Lavender oil is a fragrance that many of us have experienced in growing up at home and is also popular today. The lavender plant belongs to the Labitae family and has been used for centuries in dried or essential oil form. Lavender obtained from flower heads and leaves with vapor distillation. Traditionally, this oil is believed to be beneficial for antibacterial, antifungal, muscle relaxant, sedative, antidepressant effects and for burn and insect bites. Nowadays it is used for aromatherapy and antibacterial and pleasant fragrance material which is used in soaps and cosmetic products. This oil has also been specifically investigated and is an essential oil scientifically shown to reduce patient anxiety before various surgeries. However, the anxiolytic effect of this essential oil has not been investigated for orthognatic surgery patients and there is very few studies investigating different concentrations.

The aim of our study is to investigate whether the different concentration of lavender oil diffused in the preoperative environment of orthognathic surgery patients reduces preoperative anxiety.

Conditions

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Anxiety Osteotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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No lavender

No mist will be diffused into the environment.

Group Type NO_INTERVENTION

No interventions assigned to this group

0,1 lavender

0,1 ml lavender oil diluted in 120 ml water will be diffused into the environment with (17-33 ml mist output per hour).

Group Type ACTIVE_COMPARATOR

Supplementary Medicine

Intervention Type BEHAVIORAL

A diffuser containing 120 ml water and 0.1 or 0.3 ml lavender oil (according to arm) will be set into the patients' rooms to mist at least 30 minutes before the patients arrive.

0,3 lavender

0,3 ml lavender oil diluted in 120 ml water will be diffused into the environment with (17-33 ml mist output per hour).

Group Type ACTIVE_COMPARATOR

Supplementary Medicine

Intervention Type BEHAVIORAL

A diffuser containing 120 ml water and 0.1 or 0.3 ml lavender oil (according to arm) will be set into the patients' rooms to mist at least 30 minutes before the patients arrive.

Interventions

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Supplementary Medicine

A diffuser containing 120 ml water and 0.1 or 0.3 ml lavender oil (according to arm) will be set into the patients' rooms to mist at least 30 minutes before the patients arrive.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* To undergo orthognathic surgery
* To be over 18 years old.
* Volunteering to fill pre-operative anxiety tests

Exclusion Criteria

* Hypersensitivity to lavender and its products.
* Being on any medication.
* Being a psychiatric or psychological problem and being under treatment.
* Current upper airway infection or asthma story.
* Not want to be involved in the work.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Poyzan Bozkurt

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Poyzan Bozkurt, DDS PhD

Role: STUDY_DIRECTOR

Ankara University Faculty of Dentistry

Locations

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Ankara University Faculty of Dentistry

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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15/10

Identifier Type: -

Identifier Source: org_study_id

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