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Anxiolytic Effects of Lavender and Orange Oil

Primary Purpose

Anxiety State, Pediatric ALL, Dental Anxiety

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

About this trial

This is an interventional supportive care trial for Anxiety State focused on measuring Perioperative Anxiety, Lavender Oil, Orange Oil, Pediatric Dentistry, Deep Sedation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

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 Intervention

Lavender

Orange

Arm Description

No mist will be diffused into the environment.

0,3 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 orange 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(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).

Secondary Outcome Measures

Full Information

First Posted
September 3, 2019
Last Updated
January 24, 2020
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT04079309
Brief Title
Anxiolytic Effects of Lavender and Orange Oil
Official Title
Anxiolytic Effects of Lavender and Orange Oil on Parents of Pediatric Patients With Dental Treatment Under Sedation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
January 15, 2020 (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 anxiety reducing effects of lavender oil and orange oil on parents with children receiving dental care under sedation during perioperative wait.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State, Pediatric ALL, Dental Anxiety, Oil; Inhalation, Anesthesia
Keywords
Perioperative Anxiety, Lavender Oil, Orange Oil, Pediatric Dentistry, Deep Sedation

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 Intervention
Arm Type
No Intervention
Arm Description
No mist will be diffused into the environment.
Arm Title
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).
Arm Title
Orange
Arm Type
Active Comparator
Arm Description
0,3 ml orange 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)
Lavender/Orange
Intervention Description
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 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(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).
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
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Ankara University Faculty of Dentistry
City
Ankara
ZIP/Postal Code
06560
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Anxiolytic Effects of Lavender and Orange Oil

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