- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03388736
Anxiolytic Effect of Lavender Oil on Orthognathic Surgery Patients
Effects of Lavender Oil at Different Concentrations in the Preoperative Waiting Room on Anxiety Levels of Patients Before Orthognathic Surgery
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06940
- Ankara University Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No lavender
No mist will be diffused into the environment.
|
|
Active Comparator: 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).
|
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.
|
Active Comparator: 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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
STAI will be applied at administration and after 1 hour waiting time.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Poyzan Bozkurt, DDS PhD, Ankara University Faculty of Dentistry
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
Clinical Trials on Supplementary Medicine
-
Children's Hospital of Eastern OntarioHeart and Stroke Foundation of Ontario; Variety Village; City of Toronto Parks...CompletedCardiomyopathy | Congenital Heart Defects | Inherited Cardiac ArrhythmiasCanada
-
Medicontur Medical Engineering LtdMedevise ConsultingRecruitingRefractive Errors | Presbyopia | Residual AstigmatismBelgium, France, Spain, United Kingdom
-
Hôpital FribourgeoisRecruitingColorectal AdenocarcinomaSwitzerland
-
University Hospital, LilleCompleted
-
University of CalgaryRecruiting
-
Inje UniversityDongtan Sacred Heart HospitalNot yet recruiting
-
Tuberculosis Research Centre, IndiaLondon School of Hygiene and Tropical Medicine; Queen Mary University of London and other collaboratorsActive, not recruitingTuberculosis | Malnutrition, ChildIndia
-
Dongtan Sacred Heart HospitalCompletedParkinsonian DisordersKorea, Republic of
-
University of British ColumbiaCompletedVascular Diseases | Stroke | Cerebrovascular Disorders | Brain Diseases | Central Nervous System Diseases | Nervous System Diseases | Brain Ischemia | Cerebral Infarction | Brain Infarction | Cerebrovascular AccidentCanada
-
Tufts UniversityWashington University School of Medicine; United States Agency for International... and other collaboratorsCompletedModerate Acute MalnutritionSierra Leone