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Completed

NCT Number: NCT03388736

Anxiolytic Effect of Lavender Oil on Orthognathic Surgery Patients

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Faculty of Dentistry

Ankara, 06940, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supplementary Medicine

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.

Primary outcomes

  1. Reduction of preoperative anxiety

    Time frame: STAI will be applied at administration and after 1 hour waiting time.

    State Trait Anxiety Inventory (STAI) questionnaire will be applied. Turkish STAI consists of 2 questionnaires. The first survey measures state anxiety, while the second survey measures continuing anxiety.The State and Trait Anxiety Inventory-STAI (State and Trait Anxiety Scale) is a self-assessing and self-reporting anxiety questionnaire. The reliability and validity of the questionnaire are proven by numerous studies and the Turkish version is a reliable and valid questionnaire.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Effects of Lavender Oil at Different Concentrations in the Preoperative Waiting Room on Anxiety Levels of Patients Before Orthognathic Surgery

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 3, 2018
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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