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Anxiolytic Effect of Lavender Oil on Orthognathic Surgery Patients

Primary Purpose

Anxiety, Osteotomy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supplementary Medicine
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring preoperative, anxiety, orthognathic surgery, lavender oil

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ankara University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

No lavender

0,1 lavender

0,3 lavender

Arm Description

No mist will be diffused into the environment.

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

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

Outcomes

Primary Outcome Measures

Reduction of preoperative anxiety
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.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2017
Last Updated
July 2, 2019
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT03388736
Brief Title
Anxiolytic Effect of Lavender Oil on Orthognathic Surgery Patients
Official Title
Effects of Lavender Oil at Different Concentrations in the Preoperative Waiting Room on Anxiety Levels of Patients Before Orthognathic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Osteotomy
Keywords
preoperative, anxiety, orthognathic surgery, lavender oil

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No lavender
Arm Type
No Intervention
Arm Description
No mist will be diffused into the environment.
Arm Title
0,1 lavender
Arm Type
Active Comparator
Arm Description
0,1 ml lavender oil diluted in 120 ml water will be diffused into the environment with (17-33 ml mist output per hour).
Arm Title
0,3 lavender
Arm Type
Active Comparator
Arm Description
0,3 ml lavender oil diluted in 120 ml water will be diffused into the environment with (17-33 ml mist output per hour).
Intervention Type
Behavioral
Intervention Name(s)
Supplementary Medicine
Intervention Description
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 Outcome Measure Information:
Title
Reduction of preoperative anxiety
Description
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.
Time Frame
STAI will be applied at administration and after 1 hour waiting time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Poyzan Bozkurt, DDS PhD
Organizational Affiliation
Ankara University Faculty of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Ankara University Faculty of Dentistry
City
Ankara
ZIP/Postal Code
06940
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Anxiolytic Effect of Lavender Oil on Orthognathic Surgery Patients

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