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临床试验/NCT03388736
NCT03388736已完成不适用

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

Ankara University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Reduction of preoperative anxiety

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

No lavender

No Intervention

No mist will be diffused into the environment.

0,1 lavender

Active Comparator

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

干预措施: Supplementary Medicine (Behavioral)

0,3 lavender

Active Comparator

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

干预措施: Supplementary Medicine (Behavioral)

结局指标

主要结局

Reduction of preoperative anxiety

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Poyzan Bozkurt

Specialist

Ankara University

研究点 (2)

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