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Anxiolytic Effects of Lavender and Orange Oil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04079309
Recruitment Status : Completed
First Posted : September 6, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Cagil Vural, Ankara University

Brief Summary:
The aim of this study is to determine the possible anxiety reducing effects of lavender oil and orange oil on parents with children receiving dental care under sedation during perioperative wait.

Condition or disease Intervention/treatment Phase
Anxiety State Pediatric ALL Dental Anxiety Oil; Inhalation Anesthesia Behavioral: Lavender/Orange Not Applicable

Detailed Description:

Anxiety is a common problem for parents with children under sedation. It has long been known that operations, unconsciousness, the risks of the anesthesia and airway problems can cause a considerable amount of anxiety. Anxiety is associated with an uncertain psychological distress , and may vary to minor disturbances to extreme stress. The study aims to help parents improve their satisfaction by reducing their anxiety levels and ensure they have a better experience. In addition, anxiety can also prevent active participation of the parents during postoperative recovery. 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 is obtained from flower heads and leaves with vapor distillation. This oil has also been specifically investigated and is an essential oil scientifically shown to reduce patient anxiety before various interventions. Orange oil is an essential oil produced by cells within the rind of an orange fruit (Citrus sinensis fruit). In contrast to most essential oils, it is extracted as a by-product of orange juice production by centrifugation, producing a cold-pressed oil. It is composed of mostly d-limonene. This oil has been investigated and shown to reduce anxiety and improve mood before various interventions.The anxiolytic effects of these essential oils has not been investigated for parents with children undergoing pediatric dental procedures under sedation.

The aim of this study is to investigate the effects of lavender oil and orange oil diffused in the perioperative waiting room of parents with children under sedation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Anxiolytic Effects of Lavender and Orange Oil on Parents of Pediatric Patients With Dental Treatment Under Sedation
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: No Intervention
No mist will be diffused into the environment.
Active Comparator: 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).
Behavioral: Lavender/Orange
A diffuser containing 120 ml water and 0.3 ml lavender oil / 0.3 ml orange oil will be set into the parents' perioperative waiting rooms to mist at least 1 hour before the parent arrive.

Active Comparator: Orange
0,3 ml orange oil diluted in 120 ml water will be diffused into the environment with (17-33 ml mist output per hour).
Behavioral: Lavender/Orange
A diffuser containing 120 ml water and 0.3 ml lavender oil / 0.3 ml orange oil will be set into the parents' perioperative waiting rooms to mist at least 1 hour before the parent arrive.




Primary Outcome Measures :
  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(20 questions each).The STAI 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.

    All questions are rated on a 4-point scale (from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

    Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval (Spielberger et al., 1983). Test-retest coefficients for this measure in the present study ranged from .69 to .89. Considerable evidence attests to the construct and concurrent validity of the scale (Spielberger, 1989).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

To be the parent of a child undergoing pediatric procedures under deep sedation.

To be over 18 years old. Volunteering to fill pre-operative anxiety tests.

Exclusion Criteria:

Hypersensitivity to lavender/orange 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 study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079309


Locations
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Turkey
Ankara University Faculty of Dentistry
Ankara, Turkey, 06560
Sponsors and Collaborators
Ankara University
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Responsible Party: Cagil Vural, Lecturer, Ankara University
ClinicalTrials.gov Identifier: NCT04079309    
Other Study ID Numbers: 09/05
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cagil Vural, Ankara University:
Perioperative Anxiety
Lavender Oil
Orange Oil
Pediatric Dentistry
Deep Sedation
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders